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Accutest Value+ Strep A Rapid Test Strip

FDA UDI

Class I (US FDA UDI)

by Jant Pharmacal Corp.

Identity

Trade Name
Accutest Value+ Strep A Rapid Test Strip FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Strep A Rapid Test Strip (Throat Swab) FDA UDI
Model / Reference
ID513 FDA UDI
Description
Strep A Rapid Test Strip (Throat Swab) FDA UDI

Identifiers

Primary DI / UDI-DI
10763924513199 FDA UDI
510(k) Number
K983386 FDA UDI
FDA Product Code
GTY FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3740 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

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: Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Accutest Value+ Strep A Rapid Test Strip by Jant Pharmacal Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jant Pharmacal Corp.

Sources (1)

  • FDA UDI e65f4bd6-eb37-42c4-9f6e-8c5c28373c4c 34 fields · synced Jun 1, 2026