StrepPRO™ - StrepPRO™ Streptococcal Grouping Kit, rapid latex - HARDY DIAGNOSTICS

Duns Number:039981550

Device Description: StrepPRO™ Streptococcal Grouping Kit, rapid latex agglutination test for Streptococcus Lan StrepPRO™ Streptococcal Grouping Kit, rapid latex agglutination test for Streptococcus Lancefield grouping, 60 testsA 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)

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More Product Details

Catalog Number

PL030HD

Brand Name

StrepPRO™

Version/Model Number

PL030HD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GTZ

Product Code Name

Antisera, All Groups, Streptococcus Spp.

Device Record Status

Public Device Record Key

87d3ec3a-574a-45ac-ac9d-72bf717241a4

Public Version Date

September 10, 2020

Public Version Number

1

DI Record Publish Date

September 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARDY DIAGNOSTICS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 630
2 A medical device with a moderate to high risk that requires special controls. 132