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IMAGEN Respiratory Screen Kit

FDA UDI

Class I (US FDA UDI)

by Oxoid Limited

Identity

Trade Name
IMAGEN Respiratory Screen Kit FDA UDI
Generic Name
Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
K612011-2 FDA UDI

Identifiers

Primary DI / UDI-DI
05032384503841 FDA UDI
510(k) Number
K973954 FDA UDI
FDA Product Code
GNW FDA UDI
GMDN Term
Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

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-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

IMAGEN Respiratory Screen Kit by Oxoid Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K973954 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oxoid Limited

Sources (1)

  • FDA UDI 098ab7f1-aacc-4959-ab17-58dc36815e08 33 fields · synced Jun 8, 2026