FDA.reportPublic FDA data

Phadebact CSF Positive Controls

Primary DI
07350049850238
Brand
Phadebact CSF Positive Controls
Company
Mkl Diagnostics AB
Model
10-5593-12
Published
2018-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
07350049850238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350049850238073500498502387350049850238

GMDN Terms#

Term, Definition table
TermDefinition
Multiple meningitis-associated bacteria antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple bacteria associated with meningitis, in a clinical specimen. Bacteria detected may include Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B streptococcus or Escherichia coli (E. coli) bacteria.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
350472667
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
07350049850122Phadebact Pneumococcus Test10-5576-122018-08-20
07350049850160Phadebact Streptococcus Test10-5583-122018-08-20
07350049850177Phadebact Strep A Test10-5584-122018-08-20
07350049850184Phadebact Strep B Test10-5585-122018-08-20
07350049850191Phadebact Strep D Test10-5586-122018-08-20
07350049850207Phadebact Strep F Test10-5587-122018-08-20
07350049850214Phadebact Strep Positive Controls10-5590-122018-08-20
07350049850245Phadebact GC Positive Controls10-5594-122018-08-20
07350049850115Phadebact Haemophilus Test10-5575-1210-5575-122016-11-17
07350049850221Phadebact CSF Test10-5592-1210-5592-122016-11-17
07350049850269Phadebact Monoclonal GC Test 10-6419-1210-6419-122016-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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