← Back to catalogue

Prolex Group A Streptococcal Xtra Latex Reagent

FDA UDI

Class I (US FDA UDI)

by Pro-Lab, Incorporated

Identity

Trade Name
Prolex Group A Streptococcal Xtra Latex Reagent FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent FDA UDI
Device Name
Group A Latex Reagent FDA UDI
Model / Reference
PL.1031 FDA UDI
Description
Group A Latex Reagent FDA UDI

Identifiers

Catalog Number
PL.1031 FDA UDI
Primary DI / UDI-DI
10628429001322 FDA UDI
FDA Product Code
GTZ FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent 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

Yes

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 nucleic acid IVD, reagent

Prolex Group A Streptococcal Xtra Latex Reagent by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Pro-Lab, Incorporated

Sources (1)

  • FDA UDI d4b0ad52-8598-46ba-8b08-447da69474ca 34 fields · synced May 30, 2026