Identity
- Trade Name
- SALMONELLA O POLY POSITIVE CONTROL FDA UDI
- Generic Name
- Salmonella paratyphi antigen IVD, control FDA UDI
- Device Name
- Salmonella O Poly Positive controls are intended for use as positive controls for salmonella somatic antigens. FDA UDI
- Model / Reference
- 1611 FDA UDI
- Description
- Salmonella O Poly Positive controls are intended for use as positive controls for salmonella somatic antigens. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684016111 FDA UDI
- FDA Product Code
- GSN FDA UDI
- GMDN Term
- Salmonella paratyphi antigen IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3085 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 paratyphi antigen IVD, control
Salmonella O Poly Positive Control by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Salmonella paratyphi antigen IVD, control.
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 ef3ee3d2-e815-4a9c-8307-d0b4a2fba4b0 33 fields · synced May 30, 2026