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 Trichomonas vaginalis Primer - 04250453100055 Catalog Number :

Device Description : Trichomonas vaginalis DNA specific primer

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR Trichomonas vaginalis Probe - 04250453100062 Catalog Number :

Device Description : Trichomonas vaginalis 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 BKV Primer - 04250453100802 Catalog Number :

Device Description : BK virus (BKV) DNA specific primer

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR BKV Probe - 04250453100819 Catalog Number :

Device Description : BK virus (BKV) 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 CMV Primer - 04250453100826 Catalog Number :

Device Description : Cytomegalovirus (CMV) DNA specific primer

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR CMV Probe - 04250453100833 Catalog Number :

Device Description : Cytomegalovirus (CMV) 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 EBV Primer - 04250453100840 Catalog Number :

Device Description : Epstein-Barr virus (EBV) DNA specific primer

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR EBV Probe - 04250453100857 Catalog Number :

Device Description : Epstein-Barr virus (EBV) 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 Parvovirus B19 Primer - 04250453100864 Catalog Number :

Device Description : Parvovirus B19 DNA specific primer

Device Class : 1

Duns Number: 312597593

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

RealStar® ASR Parvovirus B19 Probe - 04250453100871 Catalog Number :

Device Description : Parvovirus B19 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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