Identity
- Trade Name
- FRANCISELLA TULARENSIS ANTIGEN FDA UDI
- Generic Name
- Francisella tularensis antigen IVD, reagent FDA UDI
- Device Name
- Francisella Tularensis Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection. FDA UDI
- Model / Reference
- 1703 FDA UDI
- Description
- Francisella Tularensis Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684017033 FDA UDI
- FDA Product Code
- GSL FDA UDI
- GMDN Term
- Francisella tularensis antigen IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3280 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: Francisella tularensis antigen IVD, reagent
Francisella Tularensis Antigen by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 8e336c42-97c4-49ea-8d8f-e02153ab4c6f 33 fields · synced May 30, 2026