Phadebact Streptococcus Test

GUDID 07350049850160

Mkl Diagnostics AB

Multiple Beta-haemolytic Streptococcus serogroup antigen IVD, kit, agglutination
Primary Device ID07350049850160
NIH Device Record Keyb9a01b08-7299-4832-9665-cb7bbb76d5d2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhadebact Streptococcus Test
Version Model Number10-5583-12
Company DUNS350472667
Company NameMkl Diagnostics AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350049850160 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-20
Device Publish Date2018-08-20

Devices Manufactured by Mkl Diagnostics AB

07350049850122 - Phadebact Pneumococcus Test2018-09-20
07350049850160 - Phadebact Streptococcus Test2018-09-20
07350049850160 - Phadebact Streptococcus Test2018-09-20
07350049850177 - Phadebact Strep A Test2018-09-20
07350049850184 - Phadebact Strep B Test2018-09-20
07350049850191 - Phadebact Strep D Test2018-09-20
07350049850207 - Phadebact Strep F Test2018-09-20
07350049850214 - Phadebact Strep Positive Controls2018-09-20
07350049850238 - Phadebact CSF Positive Controls2018-09-20

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