Viramed Biotech AG

Viramed Biotech AG

Address:BEHRINGSTRASSE 11,PLANEGG Bavaria,DE

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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

Reagent, Borrelia Serological Reagent (LSR) (2)

Premarket Exempt

No

Clear

Borrelia B31 IgM ViraStripe® Deca Kit plus - EVIRBBSMPS1 Catalog Number : V-BBSMPS

Device Description : Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 im human serum.

Device Class : 2

Duns Number: 329748847

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Borrelia B31 IgM ViraStripe® Test Kit - EVIRBBSMUS1 Catalog Number : V-BBSMUS

Device Description : Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 im human serum.

Device Class : 2

Duns Number: 329748847

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

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