altona Diagnostics GmbH

Address:Moerkenstrasse 12,Hamburg,DE

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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

Reagents, Specific, Analyte (MVU) (10)

Premarket Exempt

Yes

Clear

RealStar® ASR Adenovirus Primer - 04250453100888 Catalog Number :

Device Description : Human adenovirus (HAdV) DNA specific primer

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR Adenovirus Probe - 04250453100895 Catalog Number :

Device Description : Human adenovirus (HAdV) DNA specific probe (FAM labeled)

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR HHV-6 Primer - 04250453100901 Catalog Number :

Device Description : Human herpesvirus 6 (HHV-6) DNA specific primer

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR HHV-6 Probe - 04250453100918 Catalog Number :

Device Description : Human herpesvirus 6 (HHV-6) DNA specific probe (ROX labeled)

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR HSV-1 Primer - 04250453100925 Catalog Number :

Device Description : Herpes simplex virus 1 (HSV-1) DNA specific primer

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR HSV-1 Probe - 04250453100932 Catalog Number :

Device Description : Herpes simplex virus 1 (HSV-1) DNA specific probe (FAM labeled)

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR HSV-2 Primer - 04250453100949 Catalog Number :

Device Description : Herpes simplex virus 2 (HSV-2) DNA specific primer

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR HSV-2 Probe - 04250453100956 Catalog Number :

Device Description : Herpes simplex virus 2 (HSV-2) DNA specific probe (Cy5 labeled)

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR VZV Primer - 04250453100963 Catalog Number :

Device Description : Varicella-zoster virus (VZV) DNA specific primer

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR VZV Probe - 04250453100970 Catalog Number :

Device Description : Varicella-zoster virus (VZV) DNA specific probe (FAM labeled)

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

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