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Proteus Poly Antiserum

FDA UDI

Class I (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
PROTEUS POLY ANTISERUM FDA UDI
Generic Name
Multiple febrile infection-associated bacteria antigen IVD, control FDA UDI
Device Name
Proteus Poly Antiserum is a positive control intended for use in febrile tests. FDA UDI
Model / Reference
1303 FDA UDI
Description
Proteus Poly Antiserum is a positive control intended for use in febrile tests. FDA UDI

Identifiers

Primary DI / UDI-DI
00695684013035 FDA UDI
FDA Product Code
GSY FDA UDI
GMDN Term
Multiple febrile infection-associated bacteria antigen IVD, control 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, control

Proteus Poly Antiserum 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, control.

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 861c4284-f40e-4f4b-a226-1d22676460ad 33 fields · synced May 30, 2026