Phadebact GC Positive Controls

Primary DI
07350049850245
Brand
Phadebact GC Positive Controls
Company
Mkl Diagnostics AB
Model
10-5594-12
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
LSCNeisseria Controls

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSCNeisseria ControlsMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350049850245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350049850245073500498502457350049850245

GMDN Terms#

Term, Definition table
TermDefinition
Neisseria gonorrhoeae 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 Neisseria gonorrhoeae bacteria, the causative agent of gonorrhoea, in a clinical specimen.

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
07350049850238Phadebact CSF Positive Controls10-5593-122018-08-20
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