FDA.reportPublic FDA data

StrepPRO™

Primary DI
00819398027984
Brand
StrepPRO™
Company
HARDY DIAGNOSTICS
Model
PL030HD
Catalog number
PL030HD
Device description
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)
Published
2020-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GTZAntisera, All Groups, Streptococcus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTZAntisera, All Groups, Streptococcus Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398027984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398027984008193980279848193980279840819398027984

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Streptococcus serological grouping IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay used to determine the serological group (or Lancefield group) of beta-haemolytic streptococci isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576028504HardyDiskZ9511Z95112026-10-09
10816576028495HardyDisk™Z9515Z95152026-10-09
00819398026086N/AY62Y622020-06-09
00816576027194HardyDisk™Z9495Z94952025-08-08
00816576027200HardyDisk™Z9491Z94912025-08-08
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384013043Latex Grouping Reagent AOXOID LIMITEDGTZ2024-06-19
05032384013050Latex Grouping Reagent BOXOID LIMITEDGTZ2024-06-19
05032384013067Latex Grouping Reagent COXOID LIMITEDGTZ2024-06-19
05032384013074Latex Grouping Reagent DOXOID LIMITEDGTZ2024-06-19
05032384013081Latex Grouping Reagent FOXOID LIMITEDGTZ2024-06-19
05032384013098Latex Grouping Reagent GOXOID LIMITEDGTZ2024-06-19
05032384519552PathoDxtra Strep Grouping Kit (60 tests)OXOID LIMITEDGTZ2024-06-19
05032384519569PathoDxtra Extraction ReagentsOXOID LIMITEDGTZ2024-06-19
05032384519576PATHODXTRA STREP GROUPING REAGENT SETOXOID LIMITEDGTZ2024-06-19
05032384519606PATHODXTRA DISPOSABLE CARDSOXOID LIMITEDGTZ2024-06-19
05032384519835PATHODXTRA STREP GROUP A LATEXOXOID LIMITEDGTZ2024-06-19
05032384519842PATHODXTRA STREP GROUP B LATEXOXOID LIMITEDGTZ2024-06-19
05032384519859PATHODXTRA STREP GROUP C LATEXOXOID LIMITEDGTZ2024-06-19
05032384519866PATHODXTRA STREP GROUP D LATEXOXOID LIMITEDGTZ2024-06-19
05032384519873PATHODXTRA STREP GROUP F LATEXOXOID LIMITEDGTZ2024-06-19
05032384519880PATHODXTRA STREP GROUP G LATEXOXOID LIMITEDGTZ2024-06-19
05032384519897PathoDxtra Polyvalent Positive ControlOXOID LIMITEDGTZ2024-06-19
05032384012954Oxoid Reaction CardsOXOID LIMITEDGTZ2024-06-18
05032384013036Oxoid Streptococcal Grouping KitOXOID LIMITEDGTZ2024-06-18
10628429000080Prolex Streptococcal Grouping Latex KitPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000110Prolex Streptococcal Grouping Reagent Latex Suspension Group APRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000134Prolex Streptococcal Grouping Reagent Latex Suspension Group BPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000158Prolex Streptococcal Grouping Reagent Latex Suspension Group CPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000172Prolex Streptococcal Grouping Reagent Latex Suspension Group DPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000196Prolex Streptococcal Grouping Reagent Latex Suspension Group FPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000219Prolex Streptococcal Grouping Reagent Latex Suspension Group GPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000233Prolex Streptococcal Grouping Reagent Extraction Reagent 1PRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000240Prolex Streptococcal Grouping Reagent Extraction Reagent 2PRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000257Prolex Streptococcal Grouping Reagent Extraction Reagent 3 (2 x 8 ml)PRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000271Prolex Streptococcal Grouping Reagent Polyvalent Positive ControlPRO-LAB, INCORPORATEDGTZ2022-12-25