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Salmonella O Group A Antigen

FDA UDI

Class II (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
SALMONELLA O GROUP A ANTIGEN FDA UDI
Generic Name
Salmonella typhi antigen IVD, kit, agglutination FDA UDI
Device Name
Salmonella O Group A Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection. FDA UDI
Model / Reference
1500 FDA UDI
Description
Salmonella O Group A Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection. FDA UDI

Identifiers

Primary DI / UDI-DI
00695684015008 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 A 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Germaine Laboratories, Inc.

Sources (1)

  • FDA UDI 1e7d306c-78a7-4e31-8466-8574cf1f00ce 33 fields · synced May 30, 2026