Identity
- Trade Name
- SALMONELLA O GROUP C ANTIGEN FDA UDI
- Generic Name
- Salmonella typhi antigen IVD, kit, agglutination FDA UDI
- Device Name
- Salmonella O Group C Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection. FDA UDI
- Model / Reference
- 1502 FDA UDI
- Description
- Salmonella O Group C Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684015022 FDA UDI
- FDA Product Code
- GRL FDA UDI
- GMDN Term
- Salmonella typhi antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Salmonella typhi antigen IVD, kit, agglutination
Salmonella O Group C Antigen by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Salmonella typhi antigen IVD, kit, agglutination.
- SALMONELLA H b ANTIGEN — GERMAINE LABORATORIES, INC. · Class II
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- SALMONELLA H d ANTIGEN — GERMAINE LABORATORIES, INC. · Class II
- SALMONELLA H c ANTIGEN — GERMAINE LABORATORIES, INC. · Class II
- SALMONELLA O GROUP D ANTIGEN — GERMAINE LABORATORIES, INC. · Class II
- SALMONELLA O GROUP B ANTIGEN — GERMAINE LABORATORIES, INC. · Class II
- SALMONELLA H a ANTIGEN — GERMAINE LABORATORIES, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI a1f360ce-4a42-4987-a16f-f3149f6e472e 33 fields · synced May 30, 2026