FDA Registration
Active
🇺🇸 United States
SCANTIBODIES LABORATORY, INC.
Reg #: 2020808
·
FEI: 2020808
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
4
Classifications
7
Registration Details
- Registration Name
- SCANTIBODIES LABORATORY, INC.
- Registration Number
- 2020808
- FEI Number
- 2020808
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9336 ABRAHAM WAY
- City
- SANTEE
- State
- CA
- ZIP
- 92071
- Country
- US
Regulatory Submissions
- 510(k) Number
- K021032
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 |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-11-18 |
| Covid-19 Multi-Analyte Antigen Device | QMN | Class N | Unknown | No | 2020-11-20 |
| Radioimmunoassay, Acth | CKG | Class 2 | Clinical Chemistry | No | 2006-01-24 |
| Campylobacter Spp. | LQP | Class 1 | Microbiology | No | 2022-02-02 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2007-12-31 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2021-01-11 |
| Plate, Silica Gel, Tlc | DKS | Class 1 | Clinical Chemistry | No | 2023-08-04 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Device in the United States for Export Only