Prolex Streptococcal Grouping Latex Kit

Primary DI
10628429000080
Brand
Prolex Streptococcal Grouping Latex Kit
Company
PRO-LAB, INCORPORATED
Model
PL.030
Catalog number
PL.030
Device description
Complete Strep Grouping Kit for Lancefield Groups A, B, C, D, F, and G.
Published
2022-12-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
10628429000080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1062842900008010628429000080

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used to determine the serological group (or Lancefield group) of beta-haemolytic streptococci isolated from a clinical specimen by culture, using an agglutination method.

Regulatory Flags#

DUNS number
960418395
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
10628429001223AmnioTest (Nitrazine yellow swab)PL.901PL.9012022-12-26
20628429001220AmnioTest (Nitrazine yellow swab 20 box)PL.901-20PL.901-202022-12-26
30628429001227AmnioTest (Nitrazine yellow swab 100 box)PL.901PL.9012022-12-26
10628429001742Legionella DFA Mounting MediumPL.213PL.2132022-12-25
10628429001049Prolex E. coli O157 Latex Test Reagent Kit (50 tests)PL.070BPL.070B2022-12-26
10628429001056Prolex E. coli O157 Latex Test Reagent Kit (100 tests)PL.071BPL.071B2022-12-26
10628429001100Prolex E. coli O157 Latex Reagent Control NegativePL.076BPL.076B2022-12-26
10628429001124Prolex E. coli Non-O157 Identification KitPL.1070PL.10702022-12-26
10628429001131Prolex E. coli O26 Latex ReagentPL.1071PL.10712022-12-26
10628429001148Prolex E. coli O45 Latex ReagentPL.1072PL.10722022-12-26
10628429001155Prolex E. coli O103 Latex ReagentPL.1073PL.10732022-12-26
10628429001162Prolex E. coli O111 Latex ReagentPL.1074PL.10742022-12-26
10628429001179Prolex E. coli O121 Latex ReagentPL.1075PL.10752022-12-26
10628429001186Prolex E. coli O145 Latex ReagentPL.1076PL.10762022-12-26
10628429001193Prolex E. coli Non-O157 Negative Control Latex ReagentPL.1077PL.10772022-12-26
10628429001209Prolex E. coli O91 Latex ReagentPL.1078PL.10782022-12-26
10628429001216E. coli O157 Antiserum (3ml)PL.6250PL.62502022-12-26
10628429001254AmnioTest Colour CardsPL.902PL.9022022-12-26
10628429000110Prolex Streptococcal Grouping Reagent Latex Suspension Group APL.031PL.0312022-12-25
10628429000134Prolex Streptococcal Grouping Reagent Latex Suspension Group BPL.032PL.0322022-12-25

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
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
10628429000295Prolex Streptococcal- Select Grouping Latex KitPRO-LAB, INCORPORATEDGTZ2022-12-25