FDA.reportPublic FDA data

BD BBL™ Streptocard™ Enzyme Latex Test Kit

Primary DI
00382902409182
Brand
BD BBL™ Streptocard™ Enzyme Latex Test Kit
Company
BECTON, DICKINSON AND COMPANY
Model
240918
Catalog number
240918
Device description
BD BBL™ Streptocard™ Enzyme Latex Test Kit, 50 Tests
Published
2018-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00382902409182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902409182003829024091823829024091820382902409182

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume39.5Milliliter

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
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
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
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30382903678717BD Vacutainer® Sodium HeparinN (NH) 75 USP Units Blood Collection Tubes3678713678712016-07-28
50885403530225BD140061-01140061-012026-05-13
50885403530232BD140063-01140063-012026-05-13
50885403530249BD140062-01140062-012026-05-13
50885403530256BD140064-01140064-012026-05-13
50885403530263BD140065-01140065-012026-05-13
50885403530270BD140066-01140066-012026-05-13
50885403530287BD140067-01140067-012026-05-13
50885403530294BD140068-01140068-012026-05-13
30382903678786BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes3678783678782016-07-28
30382903679639BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes3679633679632016-07-28
30382903679608BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units3679603679602016-07-28
30382903679615BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units3679613679612016-07-28
30382903679622BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units3679623679622016-07-28
30382903678748BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes3678743678742016-07-28
00382904422882BD BACTEC™ Myco/F Lytic Culture Vials4422884422882025-02-07
30382903672906BD Vacutainer® Multiple Sample Luer Adapter3672903672902016-12-12
30382903679875BD Vacutainer® SST™3679873679872016-07-28
30382903672876BD Vacutainer® Safety-Lok™ Blood Collection Set3672873672872016-07-28
30382903672920BD Vacutainer® Safety-Lok™ Blood Collection Set3672923672922016-07-28

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