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SAS StrepAlert

FDA UDI

by Sa Scientific, Ltd

Identity

Trade Name
SAS StrepAlert FDA UDI
Generic Name
Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The SAS™ StrepAlert is a rapid visual test for the presumptive qualitative detection of Group A streptococcal antigen from throat swab specimens. The test is for professional use only. FDA UDI
Model / Reference
611530 FDA UDI
Description
The SAS™ StrepAlert is a rapid visual test for the presumptive qualitative detection of Group A streptococcal antigen from throat swab specimens. The test is for professional use only. FDA UDI

Identifiers

Primary DI / UDI-DI
00780311000448 FDA UDI
GMDN Term
Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) 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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

SAS StrepAlert by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sa Scientific, Ltd

Sources (1)

  • FDA UDI 9371d621-3b2c-4d4b-9682-00c62d184c6f 33 fields · synced Jun 8, 2026