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Febrile Positive Control

FDA UDI

Class II (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
FEBRILE POSITIVE CONTROL FDA UDI
Generic Name
Multiple febrile infection-associated bacteria antigen IVD, control FDA UDI
Device Name
Febrile Positive Control is intended for use as a positive control for Febrile Antigen tests. FDA UDI
Model / Reference
1600 FDA UDI
Description
Febrile Positive Control is intended for use as a positive control for Febrile Antigen tests. FDA UDI

Identifiers

Primary DI / UDI-DI
00695684016005 FDA UDI
FDA Product Code
GSN FDA UDI
GMDN Term
Multiple febrile infection-associated bacteria 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: Multiple febrile infection-associated bacteria antigen IVD, control

Febrile Positive Control by Germaine Laboratories, Inc. — Class II — 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 9a721103-333c-417f-a379-c3c17267201e 33 fields · synced May 30, 2026