Phadebact Pneumococcus Test

Primary DI
07350049850122
Brand
Phadebact Pneumococcus Test
Company
Mkl Diagnostics AB
Model
10-5576-12
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
GWCAntisera, All Types, Streptococcus Pneumoniae

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWCAntisera, All Types, Streptococcus PneumoniaeMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350049850122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350049850122073500498501227350049850122

GMDN Terms#

Term, Definition table
TermDefinition
Streptococcus pneumoniae antigen IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Streptococcus pneumoniae bacteria in a clinical specimen, using an agglutination method.

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
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
07350049850238Phadebact CSF Positive Controls10-5593-122018-08-20
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
05713106105573ImmuView S. pneumoniae and L. pneumophila urinary antigen testSsi Diagnostica A/SGWC2022-10-25
05713106549919ImmuLex Strep-B kit, 10 x 1.5 mLSsi Diagnostica A/SGWC2021-08-01
05713106663981ImmuLex S. pneumoniae Type 4, 1.5 mLSsi Diagnostica A/SGWC2021-08-01
05713106732656ImmuLex Streptococcus Group Kit, 6 x 1.5 mLSsi Diagnostica A/SGWC2021-08-01
05713106732663Pneumococcus Factor 6d serum, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768549Pneumococcus Type 1 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768563Pneumococcus Type 2 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768587Pneumococcus Type 3 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768594Pneumococcus Type 4 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768648Pneumococcus Type 5 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768662Pneumococcus Type 8 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768679Pneumococcus Type 14 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768693Pneumococcus Type 20 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768716Pneumococcus Group 6 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768730Pneumococcus Group 7 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768778Pneumococcus Group 10 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768822Pneumococcus Group 11 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769119Pneumococcus Group 12 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769133Pneumococcus Group 15 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769140Pneumococcus Group 17 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769157Pneumococcus Group 18 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769164Pneumococcus Group 33 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769171Pneumococcus Factor 6b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769188Pneumococcus Factor 7b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769201Pneumococcus Factor 9d serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769218Pneumococcus Factor 9e serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769232Pneumococcus Factor 19b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769249Pneumococcus Factor 19c serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769256Pneumococcus Factor 22b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769270Pneumococcus Factor 23b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01