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StrepPRO™

FDA UDI

Class I (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name
StrepPRO™ FDA UDI
Generic Name
Beta-haemolytic Streptococcus serological grouping IVD, reagent FDA UDI
Device Name
StrepPRO™ Streptococcal Grouping Kit, rapid latex agglutination test for Streptococcus Lancefield grouping, 60 tests A unique streptococcal grouping latex agglutination kit for the rapid identification of group A, B, C, D, F, and G Streptococcus from culture. Each kit contains: * PL031HD Blue Latex Suspension Group A, 3ml 1 vial/kit (00819398027854) * PL032HD Blue Latex Suspension Group B, 3ml 1 vial/kit (00819398027861) * PL033HD Blue Latex Suspension Group C, 3ml 1 vial/kit (00819398027878) * PL034HD Blue Latex Suspension Group D, 3ml 1 vial/kit (00819398027885) * PL035HD Blue Latex Suspension Group F, 3ml 1 vial/kit (00819398027892) * PL036HD Blue Latex Suspension Group G, 3ml 1 vial/kit (00819398027908) * PL037HD Extraction Reagent 1, 3.5ml 1 vial/kit (00819398027915) * PL038HD Extraction Reagent 2, 3.5ml 1 vial/kit (00819398027922) * PL039HD Extraction Reagent 3, 8.5ml 2 vials/kit (00819398027939) * PL040HD Polyvalent Positive Control, 3.5ml 1 vial/kit (00819398027946) * PL092HD Latex Test Cards 48 cards/kit (00819398027977) * Mixing Sticks 300 sticks/kit (00819398027960) FDA UDI
Model / Reference
PL030HD FDA UDI
Description
StrepPRO™ Streptococcal Grouping Kit, rapid latex agglutination test for Streptococcus Lancefield grouping, 60 tests A unique streptococcal grouping latex agglutination kit for the rapid identification of group A, B, C, D, F, and G Streptococcus from culture. Each kit contains: * PL031HD Blue Latex Suspension Group A, 3ml 1 vial/kit (00819398027854) * PL032HD Blue Latex Suspension Group B, 3ml 1 vial/kit (00819398027861) * PL033HD Blue Latex Suspension Group C, 3ml 1 vial/kit (00819398027878) * PL034HD Blue Latex Suspension Group D, 3ml 1 vial/kit (00819398027885) * PL035HD Blue Latex Suspension Group F, 3ml 1 vial/kit (00819398027892) * PL036HD Blue Latex Suspension Group G, 3ml 1 vial/kit (00819398027908) * PL037HD Extraction Reagent 1, 3.5ml 1 vial/kit (00819398027915) * PL038HD Extraction Reagent 2, 3.5ml 1 vial/kit (00819398027922) * PL039HD Extraction Reagent 3, 8.5ml 2 vials/kit (00819398027939) * PL040HD Polyvalent Positive Control, 3.5ml 1 vial/kit (00819398027946) * PL092HD Latex Test Cards 48 cards/kit (00819398027977) * Mixing Sticks 300 sticks/kit (00819398027960) FDA UDI

Identifiers

Catalog Number
PL030HD FDA UDI
Primary DI / UDI-DI
00819398027984 FDA UDI
FDA Product Code
GTZ FDA UDI
GMDN Term
Beta-haemolytic Streptococcus serological grouping 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

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 Streptococcus serological grouping IVD, reagent

StrepPRO™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-haemolytic Streptococcus serological grouping IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hardy Diagnostics

Sources (1)

  • FDA UDI 87d3ec3a-574a-45ac-ac9d-72bf717241a4 36 fields · synced May 30, 2026