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Prolex Streptococcal Xtra Select Kit

FDA UDI

Class I (US FDA UDI)

by Pro-Lab, Incorporated

Identity

Trade Name
Prolex Streptococcal Xtra Select Kit FDA UDI
Generic Name
Multiple Streptococcus bacterial species culture isolate identification IVD, reagent FDA UDI
Device Name
Choose two vials of Group A or B Latex Reagent (3.0ml each) Polyvalent Positive Control (2.0 ml) Extraction Reagent (2 x 8.0 ml) Agglutination Cards (20) Mixing Sticks (150) FDA UDI
Model / Reference
PL.1042 FDA UDI
Description
Choose two vials of Group A or B Latex Reagent (3.0ml each) Polyvalent Positive Control (2.0 ml) Extraction Reagent (2 x 8.0 ml) Agglutination Cards (20) Mixing Sticks (150) FDA UDI

Identifiers

Catalog Number
PL.1042 FDA UDI
Primary DI / UDI-DI
10628429001360 FDA UDI
FDA Product Code
GTZ FDA UDI
GMDN Term
Multiple Streptococcus bacterial species culture isolate identification 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

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: Multiple Streptococcus bacterial species culture isolate identification IVD, reagent

Prolex Streptococcal Xtra Select Kit by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pro-Lab, Incorporated

Sources (1)

  • FDA UDI 2a9b3d23-9769-495e-8eff-6d3b1e170be8 34 fields · synced Jun 1, 2026