Mkl Diagnostics AB

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Antisera, All Groups, Streptococcus Spp. (GTZ) (3) Antigens, All Groups, Streptococcus Spp. (GTY) (1) Antisera, All Groups, N. Meningitidis (GTJ) (1) Antisera, All Types, H. Influenza (GRP) (1) Antisera, All Types, Streptococcus Pneumoniae (GWC) (1)

Premarket Exempt

No Yes

Clear

Phadebact Haemophilus Test - 07350049850115 Catalog Number : 10-5575-12

Device Class : 2

Duns Number: 350472667

Premarket Exempt : Yes

Product Code : GRP

Prescription Use : No

Device Count : 1

Phadebact Pneumococcus Test - 07350049850122 Catalog Number :

Device Class : 1

Duns Number: 350472667

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

Phadebact Streptococcus Test - 07350049850160 Catalog Number :

Device Class :

Duns Number: 350472667

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Phadebact Strep A Test - 07350049850177 Catalog Number :

Device Class :

Duns Number: 350472667

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Phadebact Strep B Test - 07350049850184 Catalog Number :

Device Class :

Duns Number: 350472667

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Phadebact Strep D Test - 07350049850191 Catalog Number :

Device Class : 1

Duns Number: 350472667

Premarket Exempt : Yes

Product Code : GTZ

Prescription Use : No

Device Count : 1

Phadebact Strep F Test - 07350049850207 Catalog Number :

Device Class : 1

Duns Number: 350472667

Premarket Exempt : No

Product Code : GTZ

Prescription Use : No

Device Count : 1

Phadebact Strep Positive Controls - 07350049850214 Catalog Number :

Device Class : 1

Duns Number: 350472667

Premarket Exempt : Yes

Product Code : GTY

Prescription Use : No

Device Count : 1

Phadebact CSF Test - 07350049850221 Catalog Number : 10-5592-12

Device Class : 2

Duns Number: 350472667

Premarket Exempt : Yes

Product Code : GTJ

Prescription Use : No

Device Count : 1

Phadebact CSF Positive Controls - 07350049850238 Catalog Number :

Device Class : 1

Duns Number: 350472667

Premarket Exempt : Yes

Product Code : GTZ

Prescription Use : No

Device Count : 1

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