Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019837962

FEI Number

3019837962

Entity Name

Abbott Molecular Distribution Center

City/State/Country

Itasca, IL, US

Establishment Address

1015 West Devon, Itasca, IL 60143, 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

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) 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 Abbott Bulk Universal Collection Kit (List 09N92-010) Alinity m STI Control Kit Alinity m STI Application Specification File Alinity m STI Amplification Reagent Kit Alinity m Ethanol Solution Alinity n Sample Tip (LN 0TN43-01) Alinity n Amplification Vessel (LN 0TN41-01) Alinity n Wash Vessel (LN 0TN42-01) Alinity m Transport Tube Alinity m Transport Tube Pierceable Capped Alinity m LRV Tube Alinity m Pierceable Cap Alinity m Aliquot Tube Alinity m Bottle for Ethanol Use Alinity n Eluate Tip (LN 0TN44-01) Alinity n Lysis Tube and Tip (LN 0TN40-01) Alinity m System Alinity m Lysis Solution Alinity m STI Amplification Reagent Kit Alinity m Multi-Collect Specimen Collection Kit Alinity m STI Control Kit Alinity m STI Application Specification File Alinity m Bottle for Ethanol Use Alinity m Diluent Solution Alinity m Sample Prep Kit 1 Alinity m Ethanol Solution Alinity m Vapor Barrier Solution Vysis EGR1 FISH Probe Kit SC (Specimen Characterization) (04N37-001) 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 Vysis ALK Break Apart FISH Probve Kit ProbeCheck ALK Negative Control Slides ProbeCheck ALK Negative Control Slides 06N38-005 Vysis ALK Break Apart FISH Probe Kit (06N38-053) Vysis ALK Break Apart FISH Probe Kit (06N38-033) ProbeCheck ALK Positive Control Slides 06N38-010 Vysis ALK Break Apart FISH Probe Kit 06N38-020 Vysis Paraffin Pretreatment IV and Post Hybridization Wash Buffer Kit 01N31-005 VP2000 Pretreatment Kit (08N16-001) ProbeCheck ALK Positive Control Slides Post Hybridization Wash Buffer Kit Vysis Paraffin Pretreatment IV & 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) 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 Abbott RealTime CT/NG Assay and Multi-Collection Kit, Abbott RealTime CT/NG Assay including UNG. 6L87-02 Abbott RealTime CT/NG Assay and Multi-Collection Kit Abbott RealTime EBV Abbott RealTime EBV Calibrator Kit Abbott RealTime EBV m2000 System ROW Combined Application CDROM Alinity m EBV Calibration Kit 09N43-70 Alinity m EBV Amplification Reagent Kit 09N43-091 Alinity m EBV Application Specification File 09N43-03A Alinity m EBV Amplification Reagent Kit 09N43-90 Alinity m EBV Control Kit 09N43-80 Alinity m EBV Application Specification File 09N43-07A Alinity m EBV WB CTRL Kit 09N43-082 Alinity m EBV WB AMP Kit 09N43-092 Alinity m EBV WB Application Specification File 09N43-09A Alinity m EBV WB CAL Kit 09N43-072 Alinity m STI Control Kit Alinity m Vapor Barrier Solution Alinity m Lysis Solution Alinity m System Alinity m Bottle for Ethanol Use Alinity m Ethanol Solution Alinity m Diluent Solution Alinity m Sample Prep Kit 1 Alinity m Multi-Collect Specimen Collection Kit Alinity m STI Amplification Reagent Kit Alinity m STI Application Specification File Alinity m STI Amplification Kit, Alinity m STI Control Kit Alinity m STI Application Specification File Alinity m STI Application Specification File List 09N17-05A Alinity m Multi-Collect Specimen Collection Kit List 09N19-010 Alinity m BKV Application Specification File Alinity m BKV Control Kit Alinity m BKV Calibrator Kit Alinity m BKV Amplification Reagent Kit Alinity m Cervi Collect Specimen Collection Kit Alinity m Multi Collect Specimen Collect Kit Abbott Realtime HCV GT II Alinity m Sample Prep 1 Abbott m24sp 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 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 Alinity m Sample Prep Kit 1 Alinity m Vapor Barrier Solution Alinity m HR HPV CTRL Kit Alinity m HR HPV AMP Kit Alinity m Bottle for Ethanol Use Alinity m HR HPV Application Specification File Alinity m Ethanol Solution simpli-COLLECT HPV Collection Kit (09R16-001) Alinity m Lysis Solution Alinity m Diluent Solution Alinity m Urine Transport Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	1998-06-30
QUM	Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	Microbiology	Class 2	866.3958	2007-11-26
PNK	Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)	Unknown	Class 3	N/A	2016-04-15
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-03-18
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2019-02-26
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2019-01-30
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2023-08-21
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2023-08-21
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2023-08-21
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2023-08-21
PDO	Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization	Hematology	Class 2	864.1870	2013-12-19
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	Microbiology	Class 2	866.3309	2023-08-24
OWE	Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement	Unknown	Class 3	N/A	2011-09-27
MAQ	Kit, Dna Detection, Human Papillomavirus	Unknown	Class 3	N/A	2019-01-30
OYU	Dna-Probe Kit, Human Chromosome	Immunology	Class 2	866.4700	2009-12-17
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2010-02-05
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2010-02-05
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
LSF	Dna-Reagents, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2015-04-29
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2022-05-12
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2022-05-12
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2022-05-12
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-05-12
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2022-05-12
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2008-06-05
QMI	Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna	Microbiology	Class 2	866.3183	2023-09-11
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2013-02-21
OBF	Assay, Genotyping, Hepatitis C Virus	Microbiology	Class 2	866.3170	2009-12-17
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2019-01-30
PAB	Cytomegalovirus (Cmv) Dna Quantitative Assay	Microbiology	Class 2	866.3180	2022-05-16
OYU	Dna-Probe Kit, Human Chromosome	Immunology	Class 2	866.4700	2013-11-26
MAQ	Kit, Dna Detection, Human Papillomavirus	Unknown	Class 3	N/A	2023-12-27
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.

View Entity Profile →

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
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 3019837962. Last updated year: 2026. Please use registration number 3019837962 when referencing this establishment in official correspondence.