FDA Registration
Active
🇺🇸 United States
LIFE TECHNOLOGIES CORPORATION
Reg #: 3009976420
·
FEI: 3009976420
·
Expires 2026
Products
3
Proprietary Names
7
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- LIFE TECHNOLOGIES CORPORATION
- Registration Number
- 3009976420
- FEI Number
- 3009976420
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6055 Sunol Blvd
- City
- Pleasanton
- State
- CA
- ZIP
- 94566
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233453
Owner / Operator
- Firm Name
- Life Technologies Corporation
- Operator Number
- 9915045
- Address
- 5781 Van Allen Way, --
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-03-30 |
| Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | QQX | Class 2 | Microbiology | No | 2024-10-10 |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2025-01-31 |
Proprietary Names
TaqPath COVID-19, FluA, FluB Combo Kit
TaqPath COVID-19 Combo Kit
TaqPath COVID-19 High Throughput Combo Kit
TaqPath COVID-19 Fast PCR Combo Kit 2
TaqPath COVID-19 RNase P Combo Kit 2
TaqPath COVID-19 Diagnostic PCR Kit
Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198