FDA Registration
Active
🇺🇸 United States
Labcorp Genetics
Reg #: 3013248161
·
FEI: 3013248161
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Labcorp Genetics
- Registration Number
- 3013248161
- FEI Number
- 3013248161
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1400 16th Street
- City
- San Francisco
- State
- CA
- ZIP
- 94103
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152556
Owner / Operator
- Firm Name
- Labcorp Genetics
- Operator Number
- 10087208
- Address
- 1400 16th Street
- City
- San Francisco
- State
- CA
- Postal Code
- 94103
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2023-02-07 |
| Dna Specimen Collection, Saliva | OYJ | Class 2 | Clinical Chemistry | No | 2023-02-13 |
| Phlebotomy Blood Collection Kit | OFM | Class 2 | Cardiovascular | No | 2024-06-20 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-08-17 |
Proprietary Names
Invitae RNA + Hereditary Cancer Blood Collection Kit
Invitae Saliva Collection kit
Invitae Straight Needle Phlebotomy Kit
Invitae Butterfly Needle Phlebotomy Kit
Invitae Blood PCM Collection Kit
Invitae Blood Collection Kit
Invitae Blood NDD Collection Kit
Invitae Buccal Swab Specimen Collection Kit
Invitae Buccal NDD Swab Specimen Collection Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility