FDA Registration
Active
🇺🇸 United States
Immunalysis Corporation K2 (Synthetic Cannabinoids-1) Enzyme Conjugate ASR (700 mL)
Reg #: 2020952
·
FEI: 2020952
·
Expires 2025
Products
1
Proprietary Names
95
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Alere San Diego Inc.
- Registration Number
- 2020952
- FEI Number
- 2020952
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 829 Towne Center Drive
- City
- Pomona
- State
- CA
- ZIP
- 91767
- Country
- US
Owner / Operator
- Firm Name
- Abbott
- Operator Number
- 9006731
- Address
- 100 Abbott Park Road, Dept. RX51/J55/MS 6134
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2002-11-14 |
Proprietary Names
Immunalysis Corporation K2 (Synthetic Cannabinoids-1) Enzyme Conjugate ASR (700 mL)
Immunalysis Corporation Fentanyl Enzyme Conjugate ASR 400mL
Immunalysis Corporation THC Antibody ASR 1000 mL
Immunalysis Corporation K2 (Synthetic Cannabinoids-1) Enzyme Conjugate ASR (70 mL)
Immunalysis Corporation Methadone Antibody ASR 100 mL
Immunalysis Corporation Methadone Enzyme Conjugate ASR 600mL
Immunalysis Corporation K2 (Synthetic Cannabinoids-2) Antibody ASR 100 mL
Immunalysis Corporation Tapentadol Antibody ASR 1000 mL
Immunalysis Corporation Buprenorphine Antibody ASR (1000 mL)
Immunalysis Corporation Methamphetamine Enzyme Conjugate ASR (60 mL)
Immunalysis Corporation Opiates Enzyme Conjugate ASR (60 mL)
Immunalysis Corporation Amphetamine Enzyme Conjugate ASR (600 mL)
Immunalysis Corporation Ketamine Antibody ASR 100 mL
Immunalysis Corporation Barbiturates Antibody ASR 100 mL
Immunalysis Corporation Buprenorphine Enzyme Conjugate ASR (1000 mL)
Immunalysis Corporation Benzodiazepines Antibody ASR (1000 mL)
Immunalysis Corporation Benzodiazepines Antibody ASR (100 mL)
Immunalysis Corporation Tramadol Antibody ASR 1000 mL
Immunalysis Corporation Tapentadol Antibody ASR 100 mL
Immunalysis Corporation Methamphetamine Antibody ASR (1000 mL)
Immunalysis Corporation Barbiturates Antibody ASR 1000 mL
Immunalysis Corporation K2 (Synthetic Cannabinoids-2) Antibody ASR 1000 mL
Immunalysis Corporation Amphetamine Antibody ASR (100 mL)
Immunalysis Corporation Tramadol Enzyme Conjugate ASR 70 mL
Immunalysis Corporation Cocaine/Benzoylecgonine Antibody ASR (100 mL)
Immunalysis Corporation Amphetamine Antibody ASR (1000 mL)
Immunalysis Corporation Benzodiazepines Enzyme Conjugate ASR (60 mL)
Immunalysis Corporation Tramadol Enzyme Conjugate ASR 700 mL
Immunalysis Corporation Tramadol Antibody ASR 100 mL
Immunalysis Corporation Meperidine Enzyme Conjugate ASR 100 mL
Immunalysis Corporation Cannabinoids Enzyme Conjugate ASR 1000 mL
Immunalysis Corporation PCP Antibody ASR (1000 mL)
Immunalysis Corporation Cocaine/Benzoylecgonine Enzyme Conjugate ASR (600 mL)
Immunalysis Corporation K2 (Synthetic Cannabinoids-1) Antibody ASR (1000 mL)
Immunalysis Corporation Methadone Enzyme Conjugate ASR 60mL
Immunalysis Corporation Meperidine Antibody ASR 1000 mL
Immunalysis Corporation Meperidine Enzyme Conjugate ASR 600 mL
Immunalysis Corporation Carisoprodol Antibody ASR 1000 mL
Immunalysis Corporation Cocaine/Benzoylecgonine Antibody ASR (1000 mL)
Immunalysis Corporation THC Enzyme Conjugate ASR 600mL
Immunalysis Corporation Meperidine Enzyme Conjugate ASR 60 mL
Immunalysis Corporation Methamphetamine Enzyme Conjugate ASR (600 mL)
Immunalysis Corporation Carisoprodol Antibody ASR 100 mL
Immunalysis Corporation PCP Antibody ASR (100 mL)
Immunalysis Corporation Oxycodone Enzyme Conjugate ASR (600 mL)
Immunalysis Corporation Barbiturates Enzyme Conjugate ASR 1000 mL
Immunalysis Corporation Buprenorphine Antibody ASR (100 mL)
Immunalysis Corporation K2 (Synthetic Cannabinoids-2) Enzyme Conjugate ASR 70 mL
Immunalysis Corporation Oxycodone Antibody ASR (1000 mL)
Immunalysis Corporation Cannabinoids Antibody ASR 100 mL
Immunalysis Corporation Methadone Antibody ASR 1000 mL
Immunalysis Corporation Opiates Antibody ASR (100 mL)
Immunalysis Corporation Tapentadol Enzyme Conjugate ASR 40mL
Immunalysis Corporation Cannabinoids Antibody ASR 1000 mL
Immunalysis Corporation Fentanyl Antibody ASR 100 mL
Immunalysis Corporation Cocaine/Benzoylecgonine Enzyme Conjugate ASR (60 mL)
Immunalysis Corporation Synthetic Cannabinoids-3 Enzyme Conjugate ASR 70 mL
Immunalysis Corporation Ethyl Alcohol Enzyme ASR 60 mL
Immunalysis Corporation Synthetic Cannabinoids-3 Antibody ASR 100 mL
Immunalysis Corporation Opiates Enzyme Conjugate ASR (600 mL)
Immunalysis Corporation Ethyl Glucuronide Enzyme Conjugate ASR 70 mL
Immunalysis Corporation Zolpidem Antibody ASR 1000 mL
Immunalysis Corporation K2 (Synthetic Cannabinoids-2) Enzyme Conjugate ASR 700 mL
Immunalysis Corporation Amphetamine Enzyme Conjugate ASR (60 mL)
Immunalysis Corporation Benzodiazepines Enzyme Conjugate ASR (600 mL)
Immunalysis Corporation Tapentadol Enzyme Conjugate ASR 400mL
Immunalysis Corporation PCP Enzyme Conjugate ASR (60 mL)
Immunalysis Corporation Fentanyl Antibody ASR 1000 mL
Immunalysis Corporation Barbiturates Enzyme Conjugate ASR 100 mL
Immunalysis Corporation Cannabinoids Enzyme Conjugate ASR 100 mL
Immunalysis Corporation Meperidine Enzyme Conjugate ASR 1000 mL
Immunalysis Corporation Buprenorphine Enzyme Conjugate ASR (100 mL)
Immunalysis Corporation Ethyl Glucuronide Antibody ASR 100 mL
Immunalysis Corporation Methamphetamine Antibody ASR (100 mL)
Immunalysis Corporation Ketamine Enzyme Conjugate ASR 700 mL
Immunalysis Corporation PCP Enzyme Conjugate ASR (600 mL)
Immunalysis Corporation Carisoprodol Enzyme Conjugate ASR 100 mL
Immunalysis Corporation Synthetic Cannabinoids-3 Enzyme Conjugate ASR 700 mL
Immunalysis Corporation THC Antibody ASR 100 mL
Immunalysis Corporation Ketamine Enzyme Conjugate ASR 70 mL
Immunalysis Corporation K2 (Synthetic Cannabinoids-1) Antibody ASR (100 mL)
Immunalysis Corporation Fentanyl Enzyme Conjugate ASR 40mL
Immunalysis Corporation Oxycodone Antibody ASR (100 mL)
Immunalysis Corporation Oxycodone Enzyme Conjugate ASR (60 mL)
Immunalysis Corporation Ethyl Glucuronide Enzyme Conjugate ASR 700 mL
Immunalysis Corporation Meperidine Antibody ASR 100 mL
Immunalysis Corporation THC Enzyme Conjugate ASR 60mL
Immunalysis Corporation Zolpidem Antibody ASR 100 mL
Immunalysis Corporation Ketamine Antibody ASR 1000 mL
Immunalysis Corporation Ethyl Glucuronide Antibody ASR 1000 mL
Immunalysis Corporation Zolpidem Enzyme Conjugate ASR 70 mL
Immunalysis Corporation Opiates Antibody ASR (1000 mL)
Immunalysis Corporation Synthetic Cannabinoids-3 Antibody ASR 1000 mL
Immunalysis Corporation Carisoprodol Enzyme Conjugate ASR 1000 mL
Immunalysis Corporation Zolpidem Enzyme Conjugate ASR 700 mL
Establishment Types
Manufacture Medical Device