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Fluoro-Check TM Strep A Test

FDA UDI

by Nano-Ditech Corporation

Identity

Trade Name
Fluoro-Check TM Strep A Test FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Time resolved fluorescence immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from throat swabs specimen to aid in the diagnosis of Group A Streptococcal infection. FDA UDI
Model / Reference
TF8149 FDA UDI
Description
Time resolved fluorescence immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from throat swabs specimen to aid in the diagnosis of Group A Streptococcal infection. FDA UDI

Identifiers

Primary DI / UDI-DI
00895160002700 FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay FDA UDI

Classification

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

Yes

FDA UDI

Category: Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay

Fluoro-Check TM Strep A Test by Nano-Ditech Corporation — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nano-Ditech Corporation

Sources (1)

  • FDA UDI c6deacc3-1514-4639-93e9-370c7241b591 33 fields · synced Jun 9, 2026