Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005248192

FEI Number

3005248192

Entity Name

ABBOTT MOLECULAR, INC.

City/State/Country

Des Plaines, IL, US

Establishment Address

1300 EAST TOUHY AVENUE, Des Plaines, IL 60018, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Abbott RealTime HIV-1 Control Kit Abbott RealTime HIV-1 Calibrator Kit Abbott RealTime HIV-1 Abbott RealTime HIV-1 Control Kit 06L18-080 HIV-1 UNG Extended Use 06L18-067, 6L87-02 Abbott RealTime HIV-1 Calibrator Kit 06L18-070 Abbott RealTime HIV-1 Extended Use 06L18-050 Abbott RealTime HIV-1 Amplification Reagent Kit 06L18-090 Abbott RealTime HIV-1 CD ROM 06L83 Abbott RealTime HIV-1 Including UNG 06L18-066, 6L87-02 Amplification Reagent Kit Vysis CLL FISH Probe Kit (04N02-020) Vysis CLLFISH Probe Kit Alinity m MPXV CTRL Kit Alinity m MPXV Application Specification File Alinity m MPXV AMP Kit Aneuvysion DNA Probe Kit (05J38-010, 05J38-030, 05J38-050) Probe Check Prenatal Positive Control Slide (05J36-005) Probe Check Normal Male Amniocyte Control Slide (05J39-005) Aneuvysion Prenatal Kit Alinity m Resp-4-Plex Application Specification File Alinity m Diluent Solution Alinity m Vapor Barrier Solution Alinity m Lysis Solution Alinity m Resp-4-Plex CTRL Kit Alinity m Sample Prep Kit 2 Alinity m Resp-4-Plex AMP Kit Alinity m System Abbott Realtime HCV GT II Alinity m System Alinity m Lysis Solution Alinity m CMV Amplification Reagent Kit Alinity m Diluent Solution Alinity m Specimen Dilution Kit I Alinity m Vapor Barrier Solution Alinity m CMV Calibrator Kit Alinity m CMV Application Specification File Alinity m CMV Control Kit Alinity m Sample Prep Kit 2 DAPI I Counterstain (1000 ng/mL) 500 ?L x 2 Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (100 mL) Enzyme Conjugate Diluent 2.5X DF with Low Sodium Bisulfite GPR (600 mL) Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (40 mL) CGH Target Slides Higher pH Antibody Diluent DF 2X NAD and G6P GPR (100 mL) VP 2000 Pretreatment Reagent (500 mL) Lower pH Enzyme Conjugate Diluent DF GPR (600 mL) Enzyme Conjugate Diluent DF GPR (700 mL) Alcohol Diluent GPR 60 mL VYSIS Paraffin Pretreatment Reagent KIT Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (400 mL) Higher pH Antibody Diluent DF 2X NAD and G6P GPR (1000 mL) VP 2000 Protease I (250 mg x 2) NICK Translation Kit Abbott Proteinase K SpectrumGreen Male Reference DNA Paraffin Pretreatment Kit III Protease Buffer II Gold dUTP rTth Polymerase DNA Activation Reagent SpectrumRed Female Reference DNA CEP Hybridization Buffer VP 2000 Protease Buffer (500 mL) SpectrumGreen Female Reference DNA AMP Check E GPR Master Mix E GPR ProbeChek MultiVysion Control Slides Abbott Bisulfite Modification Kit Vysis IntelliFish FFPE Tissue Pretreatment Protease (for 50mL) Vysis IntelliFish Universal FFPE Tissue Pretreatment and Wash Vysis IntelliFish Hybridization Buffer 1x250 uL Vysis IntelliFish FFPE Tissue Pretreatment Protease (for 500mL) Vysis IntelliFish Hybridization Buffer 5x250 uL Abbott mSample Preparation System Bulk mLysis DNA Buffer Alinity h-series AutoClean Solution (LN 01R5104) DAPI II Counterstain (125 ng/mL) VP 2000 Reagents ? Protease II (750 mg) 750 mg Orange dUTP Aqua dUTP 20X SSC, 500g RNA AMP Check VYSIS PARAFFIN PRETREATMENT KIT I SpectrumRed Male Reference DNA CGH NICK Translation Reagent Set VP 2000 Reagents ? 2N MgCl 2 (120 mL) DAPI III Counterstain (42 ng/mL) 500 ?L x 2 LSI®/WCP® Hybridization Buffer Hemo-De Solvent CGH NICK TRANSLATION REAGENTSET DNA AMP Check CGH Hybridization Reagent Kit Assembly Human Cot-1 DNA, 250 uL For Laboratory Use RNA Activation Reagent SpectrumGreen CGH Control DNA (MPE 600) NP-40 1000µL x 2 Red dUTP Antibody Diluent DF 2X NAD and G6P GPR (1000 mL) Enzyme Conjugate Diluent DF GPR (70 mL) Antibody Diluent DF with Low NAD & G6P 2X NAD & G6P GPR (1000 Ml) HEIA Enzyme Conjugate Diluent DF GPR (100 mL) HEIA Enzyme Conjugate Diluent DF GPR (1000 mL) HEIA Enzyme Conjugate Diluent DF GPR (100 mL) Green dUTP LSI®/WCP® Hybridization Buffer 2 x 500 ?L, For Laboratory Use Lower pH Enzyme Conjugate Diluent DF GPR (60 mL) Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (60 mL) Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (100 mL) Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (1000 mL) Antifade II Solution 60 ?L x 2 Taq Gold Polymerases Pretreatment Reagent 500 mL Enzyme Conjugate Diluent DF GPR (600 mL) Propidium Iodide Counterstain CGH Control DNA (MPE 600) Unlabeled Enzyme Conjugate Diluent DF GPR (60 mL) Paraffin Pretreatment Kit II FISH Specimen Pretreatment Reagent Kit Antifade Solution, 2 x 240 µL For Laboratory Use Antifade II Solution, 2 x 60 uL, For Laboratory Use VP 2000 Reagents ? 20X SSC (500 g) Antibody Diluent DF 2X NAD and G6P GPR (100 mL) VYSIS FISH Specimen Pretreatment Reagent Kit Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (1000 mL) Alinity m Labeled Tube with Pierceable Cap Alinity mp Solid Waste Disposable Container Alinity mp Sure Path Holder, Replacement Alinity mp System Alinity mp Vial Input Rack, Replacement Alinity mp Well Plate Input Rack Alinity mp Drip Tray, Replacement Alinity mp Exception Rack, Replacement Alinity mp Well Plate Alinity mp Reagent Addition Assembly Alinity mp Tube Input Rack Vysis EGR1 FISH Probe Kit SC (Specimen Characterization) (04N37-001) Abbott Realtime HCV HIV-1/HCV maxCycle CD ROM (03N23) Abbott RealTime HCV CD-ROM Alinity m Specimen Dilution Kit Alinity m HCV Control Kit Alinity m HCV Amplification Reagent Kit Alinity m HCV Application Specification File Alinity m HCV Calibrator Kit simpli-COLLECT HPV Collection Kit (09R03-040) Alinity m HR HPV Application Specification File Alinity m HR HPV Amplification Kit, Alinity m HPV Control Kit Alinity m HR HPV AMP Kit (List 09N15-092) Alinity m Specimen Buffer Kit III Alinity m Specimen Buffer Kit II simpli-COLLECT HPV Collection Kit (LN 09R03-033) simpli-COLLECT HPV Collection Kit simpli-COLLECT HPV Collection Kit (09R03-035) Alinity m STI Application Specification File Alinity m STI Amplification Kit, Alinity m STI Control Kit Vysis ALK Break Apart FISH Probe Kit (06N38-023) ProbeChek ALK Negative Control Slide Kit VP 2000 Pretreatment Kit LSI D7S486 SpectrumOrange/CEP 7 SpectrumGreen DNA Probe Vysis CEP 9 (? satellite) SpectrumOrange Probe Vysis LSI KIT SpectrumRed Probe Vysis CEP 16 (D16Z3) (satellite II) SpectrumGreen Probe Vysis MultiVysion PB Multi-color Probes Immunalysis Corporation Fentanyl Antibody ASR 1000 mL Immunalysis Corporation Cannabinoids Enzyme Conjugate ASR 100 mL Immunalysis Corporation Oxycodone Antibody ASR (1000 mL) Immunalysis Corporation K2 (Synthetic Cannabinoids-2) Antibody ASR 100 mL Immunalysis Corporation Oxycodone Enzyme Conjugate ASR (60 mL) Immunalysis Corporation Methamphetamine Antibody ASR (1000 mL) Immunalysis Corporation Oxycodone Antibody ASR (100 mL) Immunalysis Corporation Benzodiazepines Enzyme Conjugate ASR (600 mL) Vysis TelVysion 15q SpectrumOrange Probe Vysis LSI D13S319 SpectrumOrange/LSI 13q34 SpectrumGreen Probes Vysis TelVysion 1p SpectrumGreen Probe Vysis CEP 4 (? satellite) SpectrumOrange Probe Vysis LSI PTEN SpectrumGold Probe Immunalysis Corporation Cocaine/Benzoylecgonine Enzyme Conjugate ASR (600 mL) Immunalysis Corporation THC Antibody ASR 1000 mL Immunalysis Corporation Opiates Enzyme Conjugate ASR (600 mL) Immunalysis Corporation Ethyl Glucuronide Antibody ASR 1000 mL Immunalysis Corporation Oxycodone Enzyme Conjugate ASR (600 mL) Vysis TelVysion 11p SpectrumGreen Probe Vysis CEP 11 (D11Z1) (? satellite) SpectrumAqua Probe Vysis CEP X (DXZ1) (? satellite) SpectrumAqua Vysis LSI EGFR SpectrumOrange/CEP 7 SpectrumGreen Probes Vysis TelVysion 5q SpectrumOrange Probe Immunalysis Corporation Methadone Antibody ASR 100 mL Vysis CEP 15 (D15Z1) (satellite III) SpectrumAqua Probe Immunalysis Corporation Ethyl Glucuronide Enzyme Conjugate ASR 700 mL Immunalysis Corporation Meperidine Antibody ASR 1000 mL Immunalysis Corporation K2 (Synthetic Cannabinoids-1) Antibody ASR (100 mL) Vysis LSI IGH/FGFR3 Dual Color Dual Fusion Probes Vysis Smith-Magenis Region LSI SMS SpectrumOrange/RARA SpectrumGreen Probes Vysis LSI PTEN SpectrumOrange / CEP 10 SpectrumGreen Probes Vysis LSI MDM2 SpectrumOrange, 20 ?L Vysis LSI CBFB Dual Color Break Apart Rearrangement Probe Vysis LSI BCR/ABL1/ASS1 Tri-color Dual Fusion Probes (20 ?L) Vysis CEP 15 (D15Z1) (satellite III) SpectrumGreen Probe Immunalysis Corporation Cocaine/Benzoylecgonine Enzyme Conjugate ASR (60 mL) Immunalysis Corporation Opiates Antibody ASR (1000 mL) Immunalysis Corporation K2 (Synthetic Cannabinoids-2) Enzyme Conjugate ASR 70 mL Immunalysis Corporation PCP Antibody ASR (100 mL) Immunalysis Corporation Zolpidem Antibody ASR 1000 mL Immunalysis Corporation Amphetamine Antibody ASR (1000 mL) Immunalysis Corporation Methamphetamine Enzyme Conjugate ASR (60 mL) Immunalysis Corporation Tapentadol Antibody ASR 1000 mL Immunalysis Corporation Carisoprodol Antibody ASR 100 mL Immunalysis Corporation Cannabinoids Antibody ASR 1000 mL Immunalysis Corporation Synthetic Cannabinoids-3 Antibody ASR 100 mL Immunalysis Corporation Opiates Enzyme Conjugate ASR (60 mL) Immunalysis Corporation Cocaine/Benzoylecgonine Antibody ASR (1000 mL) Vysis LSI IGH/CCND1 XT Dual Color Dual Fusion Probes Vysis TelVysion 5p SpectrumGreen Probe Immunalysis Corporation THC Enzyme Conjugate ASR 60mL Vysis LSI 22 (BCR) SpectrumGreen Probe Vysis CEP X (DXZ1) (? satellite) SpectrumOrange Probe Immunalysis Corporation PCP Enzyme Conjugate ASR (60 mL) Immunalysis Corporation Tapentadol Enzyme Conjugate ASR 400mL Vysis LSI KRAS SpectrumGold Probe Immunalysis Corporation Benzodiazepines Antibody ASR (100 mL) Vysis TelVysion 20p SpectrumGreen Probe Vysis LSI 1p36 SpectrumOrange/1q25 SpectrumGreen Probes and Vysis LSI 19q13 SpectrumOrange/19p13 SpectrumGreen Probes Vysis LSI RREB1 (6p25) SpectrumRed Probe Vysis LSI ZNF217 SpectrumGold Probe, 20 ?L Vysis CEP 7 (? satellite) (D7Z1) SpectrumOrange Probe Vysis TelVysion 10q SpectrumOrange Probe Vysis LSI EWSR1 (22q12) Dual Color Break Apart Rearrangement Probe Vysis CEP 2 (? satellite) (D2Z1) SpectrumOrange Probe Vysis LSI IGH Dual Color, Break Apart Rearrangement Probe Vysis CEP 10 (? satellite) SpectrumGreen Probe Vysis CEP 16 (D16Z3) (satellite II) SpectrumOrange Probe Vysis LSI BIRC3/MALT1 Dual Color Dual Fusion Probes Vysis CEP Y (DYZ1) (satellite III) SpectrumGreen Probe Vysis CEP 8 (D8Z2) (? satellite) SpectrumGreen Probe Vysis CEP 6 (D6Z1) (? satellite) SpectrumOrange Probe Vysis ToTelVysion Multi-color FISH Probe Kit Vysis LSI 1p36 Microdeletion Region Probe Vysis LSI MYC SpectrumGreen Probe Vysis TelVysion 12q SpectrumOrange Probe Vysis LSI BCL6 Dual Color Break Apart Rearrangement Probe Vysis MultiVysion PGT Multi-color FISH Probe Kit Vysis LSI SS18 (18q11.2) Dual Color Break Apart Rearrangement Probe Vysis CEP 11 (D11Z1) (? satellite) SpectrumOrange Probe Vysis LSI ERBB2 (17q12) SpectrumGreen Probe Vysis CEP 18 (D18Z1) (? satellite) SpectrumAqua Probe Vysis LSI MYC (8q24) SpectrumAqua Probe Vysis TelVysion 6q SpectrumOrangeProbe Vysis Wolf-Hirschhorn Region LSI WHS SpectrumOrange/CEP 4 SpectrumGreen Probes Vysis TelVysion 22q SpectrumOrange Probe Vysis CEP 6 (D6Z1) (? satellite) SpectrumGreen Vysis CEP 4 (? satellite) SpectrumAqua Probe Vysis LSI ZNF217 (20q13.2) SpectrumOrange Probe Vysis LSI BCL2 Dual Color Break Apart Rearrangement Probe Vysis LSI FOXO1 (13q14) Dual Color Break Apart Rearrangement Probe Vysis LSI 13q34 SpectrumGreen Probe Vysis LSI 21 SpectrumOrange Probe Vysis LSI PML/RARA Dual Color Dual Fusion Probes Vysis LSI FUS (16p11) Dual Color Break Apart Rearrangement Probe Vysis CEP 10 (? satellite) SpectrumOrange Probe Vysis LSI MYB (6q23) SpectrumGold Probe Vysis TelVysion Xp/Yp SpectrumGreen Probe Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe Vysis LSI Androgen Receptor Gene (Xq12) SpectrumOrange Probe Vysis TelVysion Xq/Yq SpectrumOrange Probe Vysis LSI SNRPN SpectrumOrange/CEP 15 SpectrumAqua/PML SpectrumGreen Probes, 10 ?L Vysis TelVysion 19p SpectrumGreen Probe Vysis LSI MALT1 Dual Color Break Apart Rearrangement Probe Vysis LSI RUNX1 SpectrumGreen Probe Vysis LSI ETV6 (TEL) / RUNX1 (AML1) ES Dual Color Single Fusion Probe Vysis D7S522/CEP 7 FISH Probe Kit Vysis LSI TRA/D Dual Color Break Apart Rearrangement Probe Vysis LSI MYB (6q23) SpectrumAqua Probe Vysis LSI D20S108 (20q12) SpectrumOrange Probe Vysis LSI LPL SpectrumOrange Probe Vysis LSI DDIT3 (12q13) Dual Color Break Apart Rearrangement Probe Vysis LSI CSF1R SpectrumOrange/D5S23,D5S721 SpectrumGreen Probes Vysis LSI IGH/MYC/CEP 8 Tri-color Dual Fusion Probes Vysis LSI MYC (8q24.12-q24.13) SpectrumOrange Probe Vysis TelVysion 13q SpectrumOrange Probe Vysis Williams Region LSI ELN SpectrumOrange/D7S486, D7S522 SpectrumGreen Probes Vysis Prader-Willi/Angelman Region LSI D15S11SpectrumOrange/CEP 15 SpectrumGreen Probes Vysis LSI TP53 Spectrum Orange / CEP 17 Spectrum Green Probe Vysis LSI ETV6 SpectrumOrange Probe Vysis TelVysion 2q SpectrumOrange Probe Vysis BRAF SpectrumGold Probe Vysis LSI CCND1 Dual Color Break Apart Rearrangement Probe Vysis CEP 17 (D17Z1) (? satellite) SpectrumGreen Probe Vysis CEP 18 (D18Z1) (? satellite) SpectrumOrange Probe Vysis DiGeorge Region LSI TUPLE 1 SpectrumOrange/LSI ARSA SpectrumGreen Probes Vysis TelVysion 18p SpectrumGreen Probe Vysis TelVysion 9q SpectrumOrange Probe Vysis LSI ATM (11q22.3) SpectrumOrange Probe Vysis CEP 15 (D15Z4) (? satellite) SpectrumOrange Probe Vysis LSI CCND1 SpectrumGreen Probe Vysis LSI CDKN2A SpectrumOrange/CEP 9 SpectrumGreen Probes Vysis LSI 4q12 Tricolor Rearrangement Probe Vysis LSI D13S25 (13q14.3) SpectrumOrange Probe Vysis LSI STS SpectrumOrange Probe CMV PRIMER ASR CMV AMP Check ASR Vysis LSI CCND1 (Tel) Specturm Orange Probe Vysis LSI DDIT3 (Tel) Spectrum Green Probe Vysis LSI FUS (Tel) Spectrum Green Probe Vysis LSI FOXO1 (Cen) SpectrumGreen Probe Vysis LSI NTRK1 (Cen) Spectrum Green Probe Vysis LSI FUS (Cen) Spectrum Orange Probe Vysis LSI FOXO1 (Tel) SpectrumOrange Probe Vysis LSI FGFR2 Specturm Orange Probe Vysis LSI RARA (Cen) SpectrumOrange Probe Vysis LSI RARA (Tel) SpectrumGreen Probe Vysis LSI MALT1 SpectrumOrange Probe Vysis LSI TCF3 SpectrumGreen Probe Vysis LSI 19p12 Spectrum Green Probe Vysis LSI HIRA Spectrum Orange Probe Vysis LSI CKS1B Spectrum Orange Probe Vysis LSI CCND1 (Cen) Spectrum Green Probe Vysis LSI DDIT3 (Cen) Spectrum Orange Probe Vysis LSI CDKN2A Spectrum Orange Probe Vysis LSI PBX1 SpectrumOrange Probe Vysis LSI CDKN2C Spectrum Green Probe Vysis LSI NTRK1 (Tel) Spectrum Red Probe Vysis LSI ETV6 (Tel) SpectrumOrange Probe Vysis LSI BIRC3 SpectrumGreen Probe Vysis LSI ETV6 (Cen) SpectrumGreen Probe Vysis LSI ACTN4 SpectrumOrange Probe Vysis LSI PDGFRA Spectrum Aqua Probe Vysis LSI 4q12 Spectrum Green Probe Vysis LSI SS18 (Tel) Spectrum Orange Probe Vysis LSI SS18 (Cen) Spectrum Green Probe Vysis LSI 4q12 Spectrum Orange Probe Vysis LSI ARSA Spectrum Green Probe Vysis LSI PTEN Spectrum Orange Probe Vysis LSI NUP214 Spectrum Orange Probe (09N25-020) Vysis LSI FGFR2 (Tel) SpectrumGreenProbe (09N23-030) Vysis LSI DEK Spectrum Green Probe (09N24-020) Vysis LSI FGFR2 (Cen) Spectrum Orange Probe (09N23-020) Vysis LSI ROS1 (Tel) SpectrumOrange Probe, 20 uL Vysis LSI ROS1 (Cen) SpectrumGreen Probe, 20 uL Vysis LSI ERG (Tel) SpectrumGreen Probe Vysis TelVysion 19q SpectrumOrange Probe Vysis CEP X (DXZ1) (? satellite) SpectrumGreen Probe Vysis CEP 10 (? satellite) SpectrumAqua Probe Vysis LSI PDGFRB (Tel) SpectrumGreen Probe Vysis TelVysion 14q SpectrumOrange Probe Vysis LSI BCR/ABL1/ASS1 Tri-color Dual Fusion Probes (50 ?L) Vysis CEP Y (DYZ3) (? satellite SpectrumOrange Probe Vysis LSI CCND1 SpectrumOrange/CEP 11 SpectrumGreen Probes Vysis LSI RUNX1/RUNX1T1 Dual Color Dual Fusion Probes Vysis LSI TP53 (17p13.1) SpectrumOrange Probe Vysis LSI EGFR SpectrumRed Probe Vysis LSI 9q34 SpectrumAqua Probe Vysis CEP 4 (? satellite) SpectrumGreen Probe Vysis CEP 9 (? satellite) SpectrumGreen Probe Vysis MET SpectrumRed Probe Vysis LSI MYC Dual Color, Break Apart Rearrangement Probe Vysis LSI BCR/ABL ES Dual Color Single Fusion Probes LSI SRY SpectrumOrange/CEP X SpectrumGreen DNA Probe Vysis TelVysion 4q SpectrumOrange Probe Vysis TelVysion 8p SpectrumGreen Probe Vysis LSI 13 (13q14) SpectrumGreen Probe Vysis CEP 17 (D17Z1) (? satellite) SpectrumAqua Probe Vysis CEP X (DXZ1) SpectrumGreen/Y (DYZ3) SpectrumOrange Probes Vysis LSI IGH/CCND1 Dual Color Dual Fusion Probes Vysis LSI IGH/MALT1 Dual Color Dual Fusion Probes Vysis CEP 11 (D11Z1) (? satellite) SpectrumGreen Probe Vysis CEP 7 (D7Z1) (? satellite) SpectrumGreen Probe Vysis LSI SRY SpectrumOrange Probe Vysis LSI BCR/ABL Dual Color Single Fusion Probes Vysis CEP Y (DYZ1) (satellite III) SpectrumOrange Probe Vysis LSI TCF3/ PBX1 Dual Color, Dual Fusion Translocation Probe, 20 ?L Vysis TelVysion 11q SpectrumOrange Probe Vysis DiGeorge Region LSI N25 SO/ ARSA SGn Probes,10 uL Cri-du-Chat Region Probe ? Vysis LSI D5S23, D5S721SpectrumGreen Probe Vysis CEP 12 (D12Z3) (? satellite) SpectrumGreen Probe Vysis LSI ZNF217 SpectrumRed Probe Vysis CEP 20 (D20Z1) SpectrumOrange Probe Vysis CEP 7 (D7Z1) (? satellite) SpectrumAqua Probe Vysis TelVysion 18q SpectrumOrange Probe Vysis LSI N-MYC (2p24.1) SpectrumOrange Probe Vysis TelVysion 17p SpectrumGreen Probe Vysis Kallmann Region LSI KAL SpectrumOrange/CEP X SpectrumGreen Probes Vysis CEP 18 (D18Z1) (? satellite) SpectrumGreen Probe Vysis IGH/MAF Dual Color Dual Fusion DNA Probe Vysis TelVysion 17q SpectrumOrange Probe Vysis LSI D5S23, D5S721 SpectrumGreen Probe Vysis LSI BCR/ABL Dual Color, Dual Fusion DNA Probe Vysis LSI TERC (3q26) SpectrumGold Probe Vysis CEP 17 (D17Z1) (? satellite) SpectrumOrange Vysis CEP 1 (D1Z5) (? satellite) SpectrumOrange Probe Vysis CEP 3 (? satellite) (D3Z1) SpectrumOrange Probe Immunalysis Corporation Amphetamine Enzyme Conjugate ASR (600 mL) Immunalysis Corporation Fentanyl Enzyme Conjugate ASR 40mL Immunalysis Corporation Barbiturates Antibody ASR 1000 mL Vysis LSI PML/RARA Dual Color Single Fusion Probes Vysis LSI MAPT 17q21 SpectrumGreen Probe Vysis LSI N-MYC SpectrumGreen/CEP 2 SpectrumOrange Probes Vysis CEP 9 (? satellite) SpectrumAqua Probe Vysis LSI TOP2A 17q21-22 SpectrumOrange Probe Vysis LSI D5S23, D5S721 SpectrumGreen/CEP 9 SpectrumAqua/CEP 15 SpectrumOrange Probes Immunalysis Corporation Ketamine Antibody ASR 1000 mL Immunalysis Corporation Amphetamine Antibody ASR (100 mL) Vysis LSI D15S10 SO/ CEP 15 SA/PML SGn Probes Immunalysis Corporation Benzodiazepines Enzyme Conjugate ASR (60 mL) Immunalysis Corporation THC Antibody ASR 100 mL Immunalysis Corporation Ketamine Antibody ASR 100 mL Immunalysis Corporation Meperidine Enzyme Conjugate ASR 600 mL Immunalysis Corporation Zolpidem Enzyme Conjugate ASR 700 mL Immunalysis Corporation Methadone Enzyme Conjugate ASR 600mL Immunalysis Corporation Meperidine Antibody ASR 100 mL Immunalysis Corporation Ethyl Alcohol Enzyme ASR 60 mL Immunalysis Corporation Buprenorphine Antibody ASR (100 mL) Vysis LSI ETV6 Dual Color Break Apart Rearrangement Probe Immunalysis Corporation Benzodiazepines Antibody ASR (1000 mL) Vysis LSI PIK3CA SpectrumGreen Probe Immunalysis Corporation Zolpidem Enzyme Conjugate ASR 70 mL Immunalysis Corporation Carisoprodol Enzyme Conjugate ASR 1000 mL Immunalysis Corporation Tramadol Enzyme Conjugate ASR 700 mL Immunalysis Corporation Ketamine Enzyme Conjugate ASR 700 mL Immunalysis Corporation Carisoprodol Antibody ASR 1000 mL Immunalysis Corporation K2 (Synthetic Cannabinoids-2) Antibody ASR 1000 mL Immunalysis Corporation Fentanyl Enzyme Conjugate ASR 400mL Immunalysis Corporation Buprenorphine Enzyme Conjugate ASR (100 mL) Immunalysis Corporation Barbiturates Enzyme Conjugate ASR 100 mL Immunalysis Corporation Synthetic Cannabinoids-3 Enzyme Conjugate ASR 70 mL Immunalysis Corporation Barbiturates Enzyme Conjugate ASR 1000 mL Immunalysis Corporation Cannabinoids Enzyme Conjugate ASR 1000 mL Immunalysis Corporation Ethyl Glucuronide Antibody ASR 100 mL Immunalysis Corporation Tapentadol Enzyme Conjugate ASR 40mL Immunalysis Corporation Buprenorphine Enzyme Conjugate ASR (1000 mL) Immunalysis Corporation Zolpidem Antibody ASR 100 mL Immunalysis Corporation K2 (Synthetic Cannabinoids-2) Enzyme Conjugate ASR 700 mL Immunalysis Corporation Buprenorphine Antibody ASR (1000 mL) Immunalysis Corporation Tramadol Antibody ASR 100 mL Immunalysis Corporation Methadone Enzyme Conjugate ASR 60mL Vysis TelVysion 8q SpectrumOrange Probe Vysis TelVysion 12p SpectrumGreen Probe Vysis Steroid Sulfatase Deficiency LSI STS SpectrumOrange/CEP X SpectrumGreen Probes Vysis TelVysion 3q SpectrumOrange Probe Vysis TelVysion 7q SpectrumOrange Probe Vysis LSI MECOM SpectrumOrange Probe Immunalysis Corporation PCP Enzyme Conjugate ASR (600 mL) Immunalysis Corporation Meperidine Enzyme Conjugate ASR 100 mL Vysis TelVysion 16p SpectrumGreen Probe Immunalysis Corporation Tramadol Antibody ASR 1000 mL Immunalysis Corporation K2 (Synthetic Cannabinoids-1) Antibody ASR (1000 mL) Vysis CEP 8 (D8Z2) (? satellite) SpectrumAqua Probe Vysis LSI MLL Dual Color, Break Apart Rearrangement Probe Vysis TelVysion 9p SpectrumGreen Probe Vysis LSI IGF1R SpectrumRed Probe Immunalysis Corporation Ketamine Enzyme Conjugate ASR 70 mL Vysis LSI MYC (8q24) SpectrumRed Probe Immunalysis Corporation Tramadol Enzyme Conjugate ASR 70 mL Immunalysis Corporation Cannabinoids Antibody ASR 100 mL Vysis Miller-Dieker Region/Isolated Lissencephaly LSI LIS1 SpectrumOrange/RARA SpectrumGreen Probes Vysis TelVysion 10p SpectrumGreen Probe Vysis LSI ATM SpectrumOrange/CEP 11 Spectrum Green Probe Vysis TelVysion 20q SpectrumOrange Probe Immunalysis Corporation THC Enzyme Conjugate ASR 600mL Immunalysis Corporation Tapentadol Antibody ASR 100 mL Immunalysis Corporation Methamphetamine Antibody ASR (100 mL) Immunalysis Corporation Fentanyl Antibody ASR 100 mL Immunalysis Corporation Meperidine Enzyme Conjugate ASR 60 mL Immunalysis Corporation K2 (Synthetic Cannabinoids-1) Enzyme Conjugate ASR (70 mL) Vysis LSI Xq13.2 (XIST) SO Probe Vysis TelVysion 3p SpectrumGreen Probe Vysis MultiVysion 4CC Multi-color Probe Vysis TelVysion 6p SpectrumGreen Probe Vysis CEP 16 (D16Z3) (satellite II) SpectrumAqua Probe Vysis TelVysion 4p SpectrumGreen Probe Vysis Prader-Willi/Angelman Region LSI GABRB3 SpectrumOrange/CEP 15 SpectrumGreen Probes Vysis CEP Y (DYZ1) (satellite III) SpectrumAqua Probe Vysis TelVysion 7p SpectrumGreen Probe Vysis LSI 13 (RB1) 13q14 SpectrumOrange Probe Vysis TelVysion 16q SpectrumOrange Probe Immunalysis Corporation Methamphetamine Enzyme Conjugate ASR (600 mL) Immunalysis Corporation Amphetamine Enzyme Conjugate ASR (60 mL) Immunalysis Corporation Ethyl Glucuronide Enzyme Conjugate ASR 70 mL Vysis LSI p16 (9p21) SpectrumRed Probe Vysis LSI TUPLE1 SpectrumOrange/TelVysion 22q SpectrumGreen Probes Vysis TelVysion 2p SpectrumGreen Probe Immunalysis Corporation Synthetic Cannabinoids-3 Enzyme Conjugate ASR 700 mL Vysis CEP 1 (satellite III) SpectrumOrange Probe Vysis LSI RPN1 SpectrumGreen Probe Vysis CEP 6 (D6Z1) (? satellite) SpectrumAqua Probe Vysis LSI MYC SpectrumGold Probe Vysis TelVysion 1q SpectrumOrange Probe Vysis LSI IGH/BCL2 Dual Color Dual Fusion Probes Immunalysis Corporation Opiates Antibody ASR (100 mL) Immunalysis Corporation Methadone Antibody ASR 1000 mL Immunalysis Corporation Barbiturates Antibody ASR 100 mL Vysis LSI PDGFRB (Cen) SpectrumOrange Probe Vysis LSI RARA Dual Color, Break Apart Rearrangement Probe Vysis TelVysion 21q SpectrumOrange Probe Immunalysis Corporation Cocaine/Benzoylecgonine Antibody ASR (100 mL) Immunalysis Corporation Synthetic Cannabinoids-3 Antibody ASR 1000 mL Immunalysis Corporation PCP Antibody ASR (1000 mL) Immunalysis Corporation Carisoprodol Enzyme Conjugate ASR 100 mL Immunalysis Corporation K2 (Synthetic Cannabinoids-1) Enzyme Conjugate ASR (700 mL) Immunalysis Corporation Meperidine Enzyme Conjugate ASR 1000 mL VYSIS D7S486/CEP 7 FISH PROBE KIT (04N78-020) Alinity m System Refurbished (08N53-32) Vysis CEP X Spectrum Orange/CEP Y Spectrum Green (07J20-050, 07J22-050) Probe Check Low Level Male (07J21-012) Probe Check Low Level Female (07J21-011) CEP__DNA Probe Kit and Slides Abbott RealTime CMV Calibrator Kit (5N23-70) Abbott RealTime CMV/EBV maxCycle with Aplification Extended Use (9N04-050) Abbott RealTime CMV m2000 System ROW Combined Application CD-Rom Ver 3(5N23-03) Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM)5N23-02) Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM (5N23-01) Abbott RealTime CMV Control Kit (5N23-80) Abbott RealTime CMV Amplification Reagent Kit (5N23-90) Alinity m CMV Calibration Kit 09N46-70 Alinity m CMV Amplification Reagent Kit 09N46-90 Alinity m CMV Application Specification File (Plasma) Alinity m CMV Application Specification File (Whole Blood) 09N46-03B Alinity m CMV Control Kit 09N46-80 Alinity m CMV WB Application Specification File 09N46-07A Alinity m CMV WB CTRL Kit (09N46-082) Alinity m CMV WB CAL Kit (09N46-072) Alinity m CMV WB AMP Kit (09N46-092) Abbott RealTime HBV Amplification Kit 02N40-090, 02N40-091 Abbott RealTime HBV Control Kit 02N40-80 Abbott RealTime HBV CD-ROM 02N43 Abbott RealTime HBV Calibrator Kit 02N40-70 Abbott Proteinase K 03L78-061 Abbott RealTime HBV Abbott RealTime CMV CD Rom 09N21 Abbott RealTime CMV Calibrator Kit 09N21-070 Abbott RealTime CMV Amplification Reagent Kit 9N21-090 Abbott RealTime CMV Control Kit 09N21-080 Alinity m EBV CAL Kit Alinity m EBV AMP Kit Alinity m EBV Application Specification File Alinity m EBV CTRL Kit Abbott RealTime mS9 Colorectal Cancer Vysis DAPI II Counterstain Vysis IntelliFISH 2X SSC Buffer Vysis IntelliFISH Cytology Wash Buffer Alinity m BKV Application Specification File Alinity m BKV Control Kit Alinity m BKV Calibrator Kit Alinity m BKV Amplification Reagent Kit Abbott mSample Preparation System DNA Abbott mSample Preparation System Abbott RealTime HCV Genotype m2000 combined App Spec 08L21 Abbott RealTime HCV Gentoype II Amplification Reagent Kit 08L21-090 Abbott RealTime HCV Genotype II Control Kit 08L21-080 Abbott RealTime HCV Genotype II Amplification Including Uracil-N-Glycosylase (UNG) 08L21-066, 6L87-02 TargetPrep DNA FFPE Sample Preparation Kit II (List No. 08N01-010) Abbott RealTime BRAF V600 E/K/D Mutations Amplification Including Uracil-N-Glycosylase (UNG) (List No. 07N60-67) TargetPrep DNA FFPE Sample Preparation Kit I (List No. 08N01-005) Abbott RealTime KRAS Control Kit (08N04-080) Abbott RealTime BRAF V600 E/K/D Mutations ROW m2000rt Application CD-ROM (List No. 07N60-01) Abbott RealTime BRAF V600 E/K/D Mutations Control Kit (List No. 07N60-80) Abbott RealTime BRAF V600 E/K/D Mutations Amplification Reagent Kit (List No. 07N60-90) Abbott RealTime KRAS Amplification Reagent Kit (08N04-090) Abbott RealTime KRAS m2000 RT Application CD ROM (08N04-001) Abbott RealTime IDH1 Amplification Reagent Kit Alinity m Resp-4-Plex AMP Kit Alinity m Resp-4-Plex CTRL Kit Alinity m Resp-4-Plex Application Specification File Alinity m STI Control Kit Alinity m STI Application Specification File Alinity m STI Amplification Reagent Kit Alinity m Ethanol Solution Alinity m Cervi Collect Specimen Collection Kit Alinity m Multi Collect Specimen Collect Kit Alinity m Sample Prep 1 Abbott m24sp Abbott RealTime MTB Assay CD-ROM (08N15-001, 08N15-002) RealTime MTB Amplification Reagent Kit (08N15-090) RealTime MTB RIF/INH Resistance Including Uracil-N-Glycosylase (UNG (08N28-067) RealTime MTB Control Kit (08N15-080) Uracil-N-Glycosylase (UNG) for use with Abbott RealTime MTB CE (08N15-067) RealTime MTB RIF/INH Resistance Amplification Reagent Kit (08N28-090) RealTime MTB RIF/INH Resistance ROW System Combined Application CD ROM (08N28-001) RealTime MTB RIF/INH Resistance Control Kit (08N28-080) Abbott MultiCollect Specimen Collection Kit 09K12 Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Cap (08L07-050) Abbott m2000 System Chlamydia Trachomatis and Neisseria Gonorrhoeae Application CD-ROM 06L98 Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae application CD ROM ver 5 (6L98-05) Abbott RealTime CT/NG Amplification Reagent Kit 08L07-91 Abbott RealTime CT/NG Control Kit 08L07-80 Abbott RealTime CT/NG Amplification Including UNG (08L07-66) Abbott Real Time CT/NG Amplification Reagent Extended Use Including UNG (08L07-067) AUTOVYSION Probechek HER-2/neu Normal Ratio Control Slides Kit, 5 Slides (02J05-010) Probechek HER-2/neu Cut-Off Ratio Control Slides Kit, 5 Slides (02J04-010) Abbott RealTime HIV-1 HIV-1 CD-ROM (01L68) m2000 System 13mm DBS PoSt Set Abbott mSample Preparation System DBS Buffer Kit Abbott RealTime HIV-1 Amplification Reagent Kit Abbott RealTime HIV-1 Qualitative CD-Rom HIV-1/HCV maxCycle CD ROM (03N23) Alinity m Specimen Dilution Kit Alinity m HIV-1 Application Specification File Alinity m HIV-1 Amplification Kit, Alinity m HIV-1 Control Kit, Alinity m HIV-1 Calibrator Kit Alinity m HIV-1 Application Specification File for DBS Supplement v2 Dried Blood Spot (DBS) Supplement v2 to the Alinity m HIV-1 Assay (LN 08N45-040) Alinity m HIV-1 Application Specification File for DBS Supplement UroVysion Bladder Cancer Kit (Kit with 20 / 100 tests) Vysis FUS Break Apart FISH Probe Kit Vysis DDIT3 Break Apart FISH Probe Kit Vysis Melanoma FISH Probe Kit Vysis MYC Break Apart FISH Probe Kit Vysis ETV6/RUNX1 DF FISH Probe Kit Vysis EGFR/CEP 7 FISH Probe Kit Vysis ZNF217 SpectrumRed FISH Probe Kit Vysis RUNX1/RUNX1T1 DF FISH Probe Kit (Vysis LSI AML1/ETO Dual Color, Dual Fusion Translocation Probe) Vysis PIK3CA SpectrumGreen FISH Probe Kit PathVysion HER-2 DNA Probe Kit II, 20 assay for Gastric Her 2 MultiVysion PB Multi-Color Probe Set Vysis RPN1/MECOM DF FISH Probe Kit Vysis D7S522/CEP 7 FISH Probe Kit PathVysion HER-2 DNA Probe Kit II, 100 assay for Gastric Her 2 Vysis LSI PMLRARA Dual Color, Dual Fusion Translocation Probe Set Vysis AURKA SpectrumGold FISH Probe Kit Vysis TRA/D Break Apart FISH Probe Kit Vysis LSI IGH/BCL2 Dual Color, Dual Fusion Translocation Probe Set Vysis LSI ATM (11q22.3) SpectrumOrange Probe Vysis BCL2 Break Apart FISH Probe Kit Vysis SS18 Break Apart FISH Probe Kit Vysis TP53/CEP 17 FISH Probe Kit Vysis TOP2A/CEP 17 Fish Probe Kit Vysis ZNF217 SpectrumGold FISH Probe Kit Vysis LSI BCR/ABL Dual Color, Dual Fusion Translocation Probe Set, 50 Assays ProbeChek Control Slides for UroVysion Bladder Cancer Kit Vysis IGH/FGFR3 DF FISH Probe Kit Vysis Prader-Willi/Angelman Region D15S10/CEP 15/PML FISH Probe Kit Vysis LSI p53/LSI ATM and LSI D13S319/ LSI 13q34/CEP 12 Multi-Color Probe Sets Vysis LSI D13S25 (13q14.3) Spectrum Orange Probe Vysis BRAF SpectrumGold FISH Probe Kit Vysis MultVysion PGT Multi-Color FISH Probe Kit Vysis LSI BCR/ABL Dual Color, Dual Fusion Translocation Probe Set, 20 Assays Vysis RARA Break Apart FISH Probe Kit Vysis BIRC3/MALT1 DF FISH Probe Kit Vysis Cervical FISH Probe Kit Vysis MYB SpectrumAqua FISH Probe Kit Vysis LSI 13 (13q14) SpectrumGreen Vysis PTEN /CEP 10 FISH Probe Kit Vysis IGH/CCND1 DF FISH Probe Kit Vysis 13q34 SpectrumGreen FISH Probe Kit Vysis CSF1R/D5S23, D5S721 FISH Probe Kit Vysis CBFB Break Apart FISH Probe Kit Vysis LSI BCR/ABL Dual Color, Singlel Fusion Translocation Probe Set Vysis ETV6 Break Apart FISH Probe Kit Vysis EWSR1 Break apart FISH Probe Kit Vysis LSI RB1 (13q14) SpectrumOrange Probe Vysis CCND1 Break Apart FISH Probe Kit Vysis MALT1 Break Apart FISH Probe Kit Vysis ATM/CEP 11 FISH Probe Kit Vysis LSI IGH Dual Color, Break Apart Rearrangement Probe Vysis 1p36/1q25 and 19q13/19p13 FISH Probe Kit Vysis ZNF217 SpectrumOrange FISH Probe Kit PathVysion HER-2 DNA Probe Kit II, 50 assay for Gastric Her 2 Vysis LSI TUPLE1 (HIRA) SpectrumOrange/LSI ARSA SpectrumGreen Probe Set Vysis 4q12 Tri-Color Rearrangement FISH Probe Kit Vysis LSI EGR1/D5S23, D5S721 Dual Color Probe Set Vysis ToTelVysion Multi-color FISH Probe Kit Vysis PML/RARA SF FISH Probe Kit Vysis LSI 21 SpectrumOrange Probe Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe Vysis MYC SpectrumOrange FISH Probe Kit Vysis BCR/ABL1/ASS1 Tri-Color DF FISH Probe Kit Vysis SRY/CEP X FISH Probe Kit Vysis IGH/MYC/CEP 8 Tri-Color DF FISH Probe Kit Vysis CCND1/CEP 11 FISH Probe Kit Vysis ALK Break Apart FISH Probe Kit ProbeChek ALK Negative Control Slides ProbeChek ALK Positive Control Slides Vysis IGH/MAF DF FISH Probe Kit Vysis LSI MLL Dual Color, Break Apart Rearrangement Probe Vysis MET SpectrumRed FISH Probe Kit Vysis LSI BCR/ABL ES Dual Color Translocation Probe Set Vysis D20S108 FISH Probe Kit Vysis TOP2A/HER-2/CEP 17 FISH Probe Kit Vysis D13S319/13q34 FISH Probe Kit Vysis D7S486/CEP 7 FISH Probe Kit Vysis 9q34 SpectrumAqua FISH Probe Kit Vysis IGH/MALT1 DF FISH Probe Kit BCR/ABL 9q34 Tricolor, Dual Fusion Translocation Probe Vysis LSI p53 (17p13.1) SpectrumOrange Probe Vysis Esophageal FISH Probe Kit Vysis FOXO1 Break Apart FISH Probe Kit Vysis D5S23, D5S721/CEP 9/CEP 15 FISH Probe Kit Vysis PDGFRB Break Apart FISH Probe Kit Vysis Prader-Willi/Angelman Region SNRPN/CEP 15/PML FISH Probe Kit Vysis LSI ETV6 (TEL)/RUNX1 (AML) ES Dual Color, Translocation Probe Set Vysis MDM2/CEP 12 FISH Probe Kit Vysis CDKN2A /CEP 9 FISH Probe Kit (Vysis LSI p16 (9p21)/CEP 9 Dual Color Probe) Vysis IGH/CCND1 XT DF FISH Probe Kit Vysis Williams Region Probe ELN/D7S486, D7S522 FISH Probe Kit Abbott Bulk Universal Collection Kit (List 09N92-010) Abbott m2000 System: Abbott m2000sp and Abbott m2000rt Alinity m HSV 1 & 2 / VZV Application Specification File Alinity m HSV 1 & 2 / VZV CTRL Kit (09N61-085) Alinity m HSV 1 & 2 / VZV AMP Kit (09N61-095) VIP2000 Upgrade Basin VP 2000 PROCESSOR VIP2000 Upgrade Slide Kit VIP2000 Updgrade Kit VP 2000 System Software AM Systems SCC Touchscreen Monitor Alinity m HSV 1 & 2 / VZV Control Kit Alinity m HSV 1 & 2 / VZV Amplification Reagent Kit Alinity m HSV 1 & 2 / VZV Application Specification File simpli-COLLECT Swab Collection Kit simpli-COLLECT Urine Collection Kit Vysis CLL FISH Probe Kit Alinity m STI Application Specification File Alinity m Ethanol Solution simpli-COLLECT Urine Collection Kit simpli-COLLECT Swab Collection Kit Alinity m STI Control Kit Alinity m STI Amplification Reagent Kit Alinity m STI Amplification Reagent Kit (09N17-092) Alinity m Urine Transport Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUM	Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	Microbiology	Class 2	866.3958	2007-11-26
OVQ	Chronic Lymphocytic Leukemia Fish Probe Kit	Immunology	Class 2	866.6040	2011-09-08
QTP	Reagents, Monkeypox Virus Nucleic Acid.	Unknown	Class N	N/A	2022-11-01
OYU	Dna-Probe Kit, Human Chromosome	Immunology	Class 2	866.4700	2009-12-17
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2025-06-25
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2018-07-26
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2020-08-26
OBF	Assay, Genotyping, Hepatitis C Virus	Microbiology	Class 2	866.3170	2009-12-17
PAB	Cytomegalovirus (Cmv) Dna Quantitative Assay	Microbiology	Class 2	866.3180	2022-05-16
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	1998-06-30
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2006-01-11
PDO	Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization	Hematology	Class 2	864.1870	2013-12-19
MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology	Class 2	866.3170	2008-06-05
MAQ	Kit, Dna Detection, Human Papillomavirus	Unknown	Class 3	N/A	2019-01-30
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2008-06-05
OWE	Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement	Unknown	Class 3	N/A	2013-11-25
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2000-01-28
PFG	Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders	Hematology	Class 2	864.1870	2013-11-25
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2019-01-30
OXP	Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment	Immunology	Class 2	866.6010	2007-12-04
KIR	Cells, Animal And Human, Cultured	Hematology	Class 1	864.2280	2007-12-04
PAB	Cytomegalovirus (Cmv) Dna Quantitative Assay	Microbiology	Class 2	866.3180	2015-08-05
MKT	Hepatitis Viral B Dna Detection	Microbiology	Class 2	866.3174	2012-01-03
PAB	Cytomegalovirus (Cmv) Dna Quantitative Assay	Microbiology	Class 2	866.3180	2017-06-01
QLX	Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna	Microbiology	Class 2	866.3183	2022-08-22
NBG	Marker, Colon	Gastroenterology, Urology	Class 2	876.1500	2012-06-07
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-05-02
QMI	Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna	Microbiology	Class 2	866.3183	2023-09-11
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2008-06-05
OBF	Assay, Genotyping, Hepatitis C Virus	Microbiology	Class 2	866.3170	2013-07-10
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2014-02-20
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2026-06-03
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2019-02-26
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2013-02-21
MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology	Class 2	866.3170	2020-04-23
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2020-04-23
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2019-01-30
MWA	System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex	Microbiology	Class 2	866.3372	2014-08-07
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2014-09-24
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2014-09-24
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2014-09-24
NTH	System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays	Immunology	Class 2	866.4700	2007-11-26
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2012-06-07
OYU	Dna-Probe Kit, Human Chromosome	Immunology	Class 2	866.4700	2013-11-26
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-03-18
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2011-03-02
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2011-03-02
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	Microbiology	Class 2	866.3309	2024-07-24
KEY	Stainer, Tissue, Automated	Pathology	Class 1	864.3800	1999-09-09
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	Microbiology	Class 2	866.3309	2023-08-24
QYA	System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home	Microbiology	Class 2	866.3385	2025-06-24
PNK	Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)	Unknown	Class 3	N/A	2016-04-15
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2023-10-06
OHZ	Urine Transport Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2023-09-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005248192. Last updated year: 2026. Please use registration number 3005248192 when referencing this establishment in official correspondence.