FDA Registration
Active
🇺🇸 United States
SCANTIBODIES LABORATORY INC.
Reg #: 3026664926
·
FEI: 3026664926
·
Expires 2026
Products
10
Proprietary Names
0
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- SCANTIBODIES LABORATORY INC.
- Registration Number
- 3026664926
- FEI Number
- 3026664926
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8005 Saint Andrews Ave
- City
- San Diego
- State
- CA
- ZIP
- 92154
- Country
- US
Regulatory Submissions
- 510(k) Number
- K030258
Owner / Operator
- Firm Name
- Scantibodies Laboratory Inc.
- Operator Number
- 2020808
- Address
- 9336 Abraham Way, --
- City
- Santee
- State
- CA
- Postal Code
- 92071
- Country
- US
- Correspondent
- Angela Cancino
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2021-12-06 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2023-01-19 |
| Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | GNX | Class 1 | Microbiology | No | 2023-01-19 |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | Class 2 | Microbiology | No | 2022-01-03 |
| Campylobacter Spp. | LQP | Class 1 | Microbiology | No | 2022-02-02 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-11-18 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2008-01-25 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2023-01-19 |
| Reagents, Clostridium Difficile Toxin | LLH | Class 1 | Microbiology | No | 2021-12-10 |
| Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | QVF | Class 2 | Microbiology | No | 2023-07-13 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device