Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2020952

FEI Number

2020952

Entity Name

Alere San Diego, Inc.

City/State/Country

Pomona, CA, US

Establishment Address

829 Towne Center Dr, Pomona, CA 91767, 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

Amphetamine Direct ELISA Kit Amphetamine Oral Fluid Enzyme Immunoassay eCup+ Drug Screening Device (REF 94615) SEFRIA Ecstasy Oral Fluid Enzyme Immunoassay 100 mL kit SEFRIA Ecstasy Oral Fluid Enzyme Immunoassay 500 mL kit SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay 100 mL Kit SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay 500 mL Kit Tapentadol Urine HEIA 100mL Kit Tapentadol Urine HEIA 60mL Wedge Kit Tapentadol Urine HEIA 25mL Kit Tapentadol Urine HEIA 500mL Kit Carisoprodol Urine HEIA Kit 100 Carisoprodol Urine HEIA Kit 25 Carisoprodol Urine HEIA Kit 60 Wedge Carisoprodol Urine HEIA Kit 500 Quantisal Saliva Collection Devices - 500 Per Box Quantisal Saliva Collection Device - 100 Per Box, Specimen Bag - 100 Per Box Quantisal Saliva Collection Device - 100 Per Box Quantisal Saliva Collection Devices - 25 Per Box Quantisal Saliva Collection Device - 10 Per Box Carisoprodol Urine HEIA Benzoylecgonine Urine HEIA Kit 25 Benzoylecgonine Urine HEIA Kit 500 Benzoylecgonine Urine HEIA Kit 100 Benzoylecgonine Urine HEIA 60mL Kit Ketamine Urine HEIA Ketamine Direct ELISA Kit Cotinine Direct ELISA Kit Ethyl Glucuronide Urine Calibrator 500 Immunalysis Tapentadol Calibrators Carisoprodol Urine Calibrator - 200 ng/mL Immunalysis AB-PINACA Calibrators Alinity c Tobramycin Calibrators (LN 09P9001) Alinity c Cannabinoids Qual Calibrator Kit (LN 09P5401) Alinity c Cannabinoids Semiquant 100 Calibrator Kit (LN 09P5402) Alinity c Ecstasy Qual Calibrator Kit (LN 09P5801) Alinity c Salicylate Calibrator Kit (LN 08P5901) Alinity c Cannabinoids Semiquant 200 Calibrator Kit (LN 09P5403) Alinity c Opiates Semiquant Calibrator Kit (LN 09P6502) Alinity c Ecstasy Semiquant Calibrator Kit (LN 09P5802) Alinity c Opiates Qual Calibrator Kit ( LN 09P6501) Cannabinoid Oral Fluid Calibrator Level 1 Immunalysis Fentanyl Calibrators Cannabinoid Oral Fluid Calibrator Level 2 Ethyl Glucuronide Urine Calibrator - 250 ng/mL Immunalysis Ketamine Calibrators Tapentadol Urine Calibrator 3 - 300ng/mL Ethyl Glucuronide Urine Calibrator - 2000 ng/mL Immunalysis Zolpidem Calibrators Immunalysis Ethyl Glucuronide Urine Calibrators Cannabinoid Oral Fluid Calibrator Level 3 Cannabinoid Oral Fluid Calibrator Level 4 Immunalysis Carisoprodol Calibrators Negative Oral Fluid Calibrator 2 Carisoprodol Urine Calibrator - 50 ng/mL Tapentadol Urine Calibrator 1 - 100ng/mL Immunalysis UR-144 Pentanoic Acid Calibrators Tapentadol Urine Calibrator 4 - 1000ng/mL Ethyl Glucuronide Urine Calibrator 1000 Immunalysis JWH-018 Pentanoic Acid Calibrators Carisoprodol Urine Calibrator - 100 ng/mL Carisoprodol Urine Calibrator - 500 ng/mL Tapentadol Urine Calibrator 2 - 200ng/mL Immunalysis Meperidine Calibrators Ecstasy Oral Fluid Calibrator Level 2 Barbiturates Urine HEIA Kit 25 Barbiturates Urine HEIA Olympus Wedge Kit 60 Barbiturates Urine HEIA Kit 500 Barbiturates Urine HEIA Kit 100 Ethyl Alcohol Enzyme Assay 25 mL Kit Ethyl Alcohol Enzyme Assay 500 mL Kit Ethyl Alcohol Enzyme Assay 60 mL Kit Ethyl Alcohol Enzyme Assay 100 mL Kit Alinity c Ethanol Calibrator Kit (LN 08P4101) Ethyl Alcohol Urine Calibrator 5 mg/dL Immunalysis Ethyl Glucuronide Calibrators SEFRIA Opiates Oral Fluid Enzyme Immunoassay 100 mL Kit SEFRIA Hydrocodone Oral Fluid eCup+ Drug Screening Device (REF 94615) SEFRIA Opiates Oral Fluid Enzyme Immunoassay 500 mL Kit SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 500mL Kit SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay Kit 100 mL Kit SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 100mL Kit SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay Kit 500 mL Kit cTHC Urine Control Set, 2 x 25mL cTHC Urine Calibrator Level 3 100, 1 x 25mL cTHC Urine Calibrator Level 2 50, 1 x 15mL THC Urine HEIA Olympus Wedge Kit 60 cTHC Urine Calibrator Level 4 200, 1 x 25mL cTHC Urine Calibrator Level 1 20, 1 x 15mL cTHC Urine Calibrator Level 1 20, 1 x 5 mL cTHC Urine Calibrator Level 4 200, 1 x 5 mL cTHC Urine Calibrator Level 2 50, 1 x 5 mL THC Urine HEIA Kit 25 cTHC Urine Calibrator Level 2 50, 1 x 25mL cTHC Urine Calibrator Level 1 20, 1 x 25mL cTHC Urine Calibrator Level 3 100, 1 x 15mL cTHC Urine Control Set, 2 x 15mL cTHC Urine Calibrator Level 3 100, 1 x 5 mL THC Urine HEIA Kit 500 THC Urine HEIA Kit 100 cTHC Urine Calibrator Level 4 200, 1 x 15mL cTHC Urine Control Set, 2 x 5 mL Tramadol Urine Control Set Tramadol Urine HEIA, 100 mL Kit Tramadol Urine HEIA, 500 mL Kit Tramadol Urine Calibrator Tramadol Urine HEIA 25 mL Kit Tramadol Urine Calibrator, 1 X 10 mL Tramadol Urine HEIA, 60 mL Wedge Kit Tramadol Urine Calibrator Set, 5 X 10mL Tramadol Urine Calibrator Set Tramadol Urine Control Set, 2 X 10 mL Tramadol Urine HEIA Kit 25 eCUP + Drug Screening Device (REF 94615) - AMT Mfg Cannabinoid Oral Fluid HEIA 500 ml Cannabinoid Oral Fluid HEIA 100 ml 6-Acetylmorphine Urine, 60 mL Wedge Kit 6-Acetylmorphine Urine Calibrator - 10 ng/mL 6-Acetylmorphine Urine HEIA Kit 25 6-Acetylmorphine Urine, 100 mL Kit 6-Acetylmorphine Urine 10 Calibrator 6-Acetylmorphine Urine, 25 mL Kit 6-Acetylmorphine Urine, 500 mL Kit 6-Acetylmorphine Urine Control Set 10, 2 x 5 mL 6-Acetylmorphine Urine Control Set Quantisal Quantisal Oral Fluid Collection Device SEFRIA Benzoylecgonine Oral Fluid 100 mL Kit SEFRIA Benzoylecgonine Oral Fluid 500 mL Kit eCup+ Drug Screening Device (REF 94615) Multi-Drug Control Set 1, 2 x 25mL Alinity c DOA MC III Controls (LN 08P6312) Alinity c DOA MC I Controls (LN 08P6310, 08P6318) Alinity c DOA MC II Controls (LN 08P6311) Alinity c Tox Controls (LN 08P6810) Multi-Drug Control Set 2, 2 x 25mL Oral Fluid PM Multi-Analyte Calibrator and Control Set Multi-Drug OF Control Set - Low and High Control AMP/6-AM Oral Fluid Control Set Multi-Drug Control Set 1, 2 x 15mL Synthetic Negative Saliva Oral Fluid Multi-Analyte Calibrator and Control Set Multi-Drug Control Set 2, 2 x 15mL Hydrocodone Oral Fluid Control Set Ecstasy Oral Fluid Control Set Ethyl Glucuronide Urine Control Set 500 Ethyl Glucuronide Urine Control Set 1000 Fentanyl Urine Control Set Immunalysis Carisoprodol Urine Control Set Cannabinoid Oral Fluid Control Set Tapentadol Urine Control Set Alinity c DOA MC Qual Calibrator 2 Kit (LN 08P6302) Alinity c Tox Qual Calibrators (LN 08P6802) Alinity c DOA MC Negative Calibrator Kit (LN 08P6305, 08P6306) Alinity c DOA MC Qual Low Calibrator 1 Kit (LN 08P6301) Alinity c Benzodiazepines Semiquant Calibrator Kit (LN 09P5202) Alinity c DOA MC Semiquant Calibrator Kit (LN 08P6303) Alinity c Tox Semiquant Calibrators (LN 08P6801) Alinity c TDM Multiconstituent Calibrator Kit (LN 08P7403, 08P7404) Alinity c Benzodiazepines Qual Calibrator Kit (LN 09P5201) Multi-Drug Calibrator Level 4 (15 mL) Negative Reference Calibrator 10 mL Kit Multi-Drug Calibrator Level 3 (15 mL) Multi-Drug Calibrator Level 1 (25mL) Hydrocodone Oral Fluid 4 AMP/6-AM Oral Fluid Calibrator Level 4 Oral Fluid Multi-Analyte Calibrator and Control Set Immunalysis Synthetic Negative Oral Fluid 100 mL Immunalysis Multi-Drug OF Calibrator Level 1 AMP/6-AM Oral Fluid Calibrator Level 1 Hydrocodone Oral Fluid 1 Immunalysis Multi-Drug OF Calibrator Level 4 Hydrocodone Oral Fluid 3 Negative Reference Calibrator Multi-Drug Calibrator Level 2 (15 mL) Multi-Drug Calibrator Level 3 (25 mL) Immunalysis Synthetic Negative Oral Fluid 500 mL Drug Free Negative Urine Calibrator AMP/6-AM Oral Fluid Calibrator Level 2 AMP/6-AM Oral Fluid Calibrator Level 3 Hydrocodone Oral Fluid 2 Immunalysis Multi-Drug OF Calibrator Level 3 Multi-Drug Calibrator Level 2 (25 mL) Immunalysis Multi-Drug OF Calibrator Level 2 Oral Fluid PM Multi-Analyte Calibrator and Control Set Multi-Drug Calibrator Level 4 (25 mL) Multi-Drug Calibrator Level 1 (15mL) Negative Urine Calibrator Cocaine/Benzoylecgonine Direct ELISA Kit Cocaine/Benzoylecgonine HEIA (Oral Fluid) Cocaine Metabolite Direct ELISA Kit Tricyclic Antidepressants Direct ELISA Kit Buprenorphine Urine Control Set Buprenorphine Urine HEIA 500 Buprenorphine Urine Calibrator Set Buprenorphine Urine HEIA 60 Buprenorphine Urine Calibrator Buprenorphine Urine HEIA 25 Buprenorphine Urine HEIA Kit 25 Buprenorphine Urine HEIA 100 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 Amphetamine Urine HEIA Kit 500 Amphetamine Urine HEIA Kit 25 Amphetamine Urine Calibrator Set Amphetamine Urine HEIA Olympus Wedge Kit 60 Amphetamine Urine Control Set 1000 Amphetamine Urine Calibrator 1000 Amphetamine Urine Calibrator 500 Amphetamine Urine Control Set 500 Amphetamine Urine HEIA Kit 100 Benzodiazepines Urine HEIA 25 mL Kit Benzodiazepines Urine HEIA 500 mL Kit Benzodiazepines Urine HEIA 100 mL Kit Benzodiazepines Urine HEIA 60 mL Kit SEFRIA Amphetamine Oral Fluid Enzyme Immunoassay 100mL Kit eCUP + Drug Screening Device (REF 94615) SEFRIA Amphetamine Oral Fluid Enzyme Immunoassay 500mL Kit SEFRIA PCP Oral Fluid Benzodiazepines Oral Fluid Enzyme Immunoassay Zolpidem Urine HEIA Benzodiazepines Direct ELISA Kit Zolpidem Direct ELISA Kit Salicylates Direct ELISA Kit SEFRIA Fentanyl Urine Kit 500 mL Fentanyl Urine Calibrator 1 ng / mL Fentanyl Urine Calibrator 2 ng / mL Fentanyl Urine Calibrator Level 1 - 1 ng/mL SEFRIA Fentanyl Urine Kit 60 mL Wedge Fentanyl Urine Calibrator 4 ng / mL SEFRIA Fentanyl Urine Kit 25 SEFRIA Fentanyl Urine Kit 100 mL Opiates Urine HEIA Kit 100 Opiates Urine HEIA Kit 500 Opiates Urine Calibrator 2000 Level 1 - 1000 ng/mL (5 mL) Opiates Urine Calibrator 2000 Level 2 - 1000 ng/mL (5 mL) Opiates Urine Calibrator 2000 Level 4 - 1000 ng/mL (5 mL) Opiates Urine HEIA Olympus Wedge Kit 60 Opiates Urine Calibrator 2000 Level 3 - 1000 ng/mL (15 mL) Opiates Urine HEIA Kit 25 Opiates Urine Calibrator 2000 Level 4 - 1000 ng/mL (15 mL) Opiates Urine Calibrator 2000 Level 1 - 1000 ng/mL (15 mL) Opiates Urine Calibrator 2000 Level 3 - 1000 ng/mL (5 mL) Opiates Urine Calibrator 2000 Level 2 - 1000 ng/mL (15 mL) Alinity c Ethanol Control Kit (LN 08P4110) Immunalysis Ethyl Glucuronide Controls Ethyl Alcohol Urine Control Set Barbiturates Direct ELISA Kit Vysis DAPI II Counterstain Vysis IntelliFISH 2X SSC Buffer Vysis IntelliFISH Cytology Wash Buffer Methadone Direct ELISA Kit Oxycodone Urine Control Set 100 Oxycodone Urine Calibrator 300 Oxycodone Urine HEIA 500 Oxycodone Urine HEIA 100 Oxycodone Urine Calibrator Set Oxycodone Urine Control Set 300 Oxycodone Urine, 60 mL Wedge Kit Oxycodone Urine Calibrator 100 Oxycodone Urine HEIA 25 EDDP Specific Urine Control Set Level 2 EDDP Specific Urine Calibrator Level 1, 100ng/mL EDDP Specific Urine, 25 mL Kit EDDP Specific Urine HEIA 25 Kit EDDP Specific Urine Calibrator Level 3 - 500 ng/mL EDDP Specific Urine Calibrator Level 4 - 1000 ng/mL EDDP Specific Urine, 500 mL Kit EDDP Specific Urine Calibrator Level 2 - 300 ng/mL EDDP Specific Urine Control Set 3, 2 x 5mL EDDP Specific Urine Calibrator Level 3, 500ng/mL EDDP Specific Urine Control Set 1, 2 x 5mL EDDP Specific Urine Calibrator Level 1 - 100 ng/ml EDDP Specific Urine, 60 mL Wedge Kit EDDP Specific Urine Calibrator Level 4, 1000ng/mL EDDP Specific Urine, 100 mL Kit EDDP Specific Urine Control Set 2, 2 x 5mL EDDP Specific Urine Calibrator Level 2, 300ng/mL EDDP Specific Urine Control Set Level 1 Ethyl Glucuronide Urine HEIA Methamphetamine Urine HEIA Kit 500 Methamphetamine Urine HEIA Kit 25 Methamphetamine Urine HEIA Kit 100 Methamphetamine Urine HEIA Olympus Wedge Kit 60 Opiates Direct ELISA Kit Buprenorphine Direct ELISA Kit Tramadol Oral Fluid HEIA Fentanyl Enzyme Immunoassay Fentanyl Direct ELISA Kit Oxycodone/Oxymorphone Direct ELISA Kit Tapentadol Urine HEIA Opiates Oral Fluid Enzyme Immunoassay Meperidine Urine HEIA Tramadol Direct ELISA Kit Morphine Specific Direct ELISA Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2012-04-30
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3610	2020-03-03
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2022-09-09
QBK	Meprobamate Test System	Clinical Toxicology	Class 2	862.3590	2020-03-17
PJD	Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device	Clinical Chemistry	Class 2	862.1675	2016-11-17
QBK	Meprobamate Test System	Clinical Toxicology	Class 2	862.3590	2019-12-19
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-15
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-15
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2015-12-15
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2012-04-30
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2019-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2019-11-29
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2016-12-19
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2016-12-19
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2019-04-04
DNN	Calibrators, Ethyl Alcohol	Clinical Toxicology	Class 2	862.3200	2019-11-29
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2020-03-03
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-15
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2015-12-15
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-12-15
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-15
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-15
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2020-03-03
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-12-15
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2015-12-15
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-15
PJD	Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device	Clinical Chemistry	Class 2	862.1675	2017-01-24
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3250	2020-03-03
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2019-11-29
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2019-12-26
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2019-11-29
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2019-12-19
MLK	Thin Layer Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2012-04-30
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-15
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-12-15
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2000-01-28
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-15
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-12-15
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2016-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2016-12-19
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2020-03-03
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2026-04-16
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2012-04-30
DIM	Gas Chromatography, Salicylate	Clinical Toxicology	Class 2	862.3830	2019-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2017-10-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-10-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-12-15
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-15
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-15
DKC	Alcohol Control Materials	Clinical Toxicology	Class 1	862.3280	2019-11-29
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2012-04-30
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-05-02
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2012-04-30
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-12-15
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-15
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-15
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2015-12-15
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-15
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-15
DMJ	Test Reagents For Ethyl Alcohol	Clinical Toxicology	Class 2	862.3040	2015-12-16
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2016-12-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-04-30

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
K970265	Drial Consultants, Inc.	ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST	1997-04-08
K051161	Quest Diagnostics, Inc.	QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)	2005-11-22
K122904	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;	2012-11-15
K121987	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST	2012-08-01
K111560	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST	2011-07-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2013	Alere San Diego, Inc.	2	Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2020952. Last updated year: 2026. Please use registration number 2020952 when referencing this establishment in official correspondence.