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Proteus Ox19 Antigen

FDA UDI

Class I (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
PROTEUS OX19 ANTIGEN FDA UDI
Generic Name
Multiple febrile infection-associated bacteria antigen IVD, kit, agglutination FDA UDI
Device Name
Proteus OX19 Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection. FDA UDI
Model / Reference
1202 FDA UDI
Description
Proteus OX19 Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection. FDA UDI

Identifiers

Primary DI / UDI-DI
00695684012021 FDA UDI
FDA Product Code
GSY FDA UDI
GMDN Term
Multiple febrile infection-associated bacteria antigen IVD, kit, agglutination FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3410 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: Multiple febrile infection-associated bacteria antigen IVD, kit, agglutination

Proteus Ox19 Antigen by Germaine Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple febrile infection-associated bacteria 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 300b0058-8dc7-4379-ac11-2d872dcad957 33 fields · synced May 29, 2026