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Status Flu A+B card

FDA UDI

Class I (US FDA UDI)

by Princeton Biomeditech Corp.

Identity

Trade Name
Status Flu A+B card FDA UDI
Generic Name
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Status Flu A+B; 22 Test Kit FDA UDI
Model / Reference
BSP-510-22-01 FDA UDI
Description
Status Flu A+B; 22 Test Kit FDA UDI

Identifiers

Catalog Number
BSP-510-22-01 FDA UDI
Primary DI / UDI-DI
10743816001195 FDA UDI
FDA Product Code
GNX FDA UDI
GMDN Term
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Status Flu A+B card by Princeton Biomeditech Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Influenza A/B virus antigen IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Princeton Biomeditech Corp.

Sources (1)

  • FDA UDI d9770861-81c5-497a-b8c1-dbd5d314cee1 36 fields · synced May 30, 2026