BIOKIT, S.A.

Address:AV. CAN MONTCAU 7,LLISSA D AMUNT Barcelona,ES

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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

System, Test, Infectious Mononucleosis (KTN) (3) Antistreptolysin - Titer/Streptolysin O Reagent (GTQ) (2) System, Test, Rheumatoid Factor (DHR) (2) C-Reactive Protein, Antigen, Antiserum, And Control (DCK) (1) Latex Agglutination Assay, Rubella (LQN) (1) System, Test, C-Reactive Protein (DCN) (1)

Premarket Exempt

No Yes

Clear

Monogen 50 TESTS - 08426950001676 Catalog Number :

Device Description : 1.4 ml REAGENT1.0 ml CONTROL +1.0 ml CONTROL –9 SLIDES

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 1

Color Mono 50 TESTS - 08426950344773 Catalog Number :

Device Description : 1.4 ml REAGENT1.0 ml CONTROL + 1.0 ml CONTROL –2 x 9 SLIDES

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 1

Rheumajet ASO 100 TESTS - 08426950457305 Catalog Number :

Device Description : 2 x 2.5 ml REAGENT1 x 1.5 ml CONTROL +1 x 1.5 ml CONTROL –2 x 9 SLIDES

Device Class : 1

Duns Number: 460055742

Premarket Exempt : Yes

Product Code : GTQ

Prescription Use : Yes

Device Count : 1

Monogen 150 TESTS - 08426950585350 Catalog Number :

Device Description : 3 x 1.4 ml REAGENT1 x 2.0 ml CONTROL +1 x 2.0 ml CONTROL –3 x 9 SLIDES

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 1

Rheumajet RF 100 TESTS - 08426950589334 Catalog Number :

Device Description : 2 x 2.5 ml REAGENT1 x 1.5 ml CONTROL +1 x 1.5 ml CONTROL –2 x 9 SLIDES

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

Rheumajet CRP 100 TESTS - 08426950589365 Catalog Number :

Device Description : 2 x 2.5 ml REAGENT1 x 1.5 ml CONTROL +1 x 1.5 ml CONTROL –2 x 9 SLIDES

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : DCN

Prescription Use : Yes

Device Count : 1

ASO Titer Control - 08426950590453 Catalog Number :

Device Description : 2 x 0.5 ml titrated control

Device Class : 1

Duns Number: 460055742

Premarket Exempt : No

Product Code : GTQ

Prescription Use : Yes

Device Count : 1

CRP Titer Control - 08426950590460 Catalog Number :

Device Description : 2 x 1 ml titrated control

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : DCK

Prescription Use : Yes

Device Count : 1

RF Titer Control - 08426950590477 Catalog Number :

Device Description : 2 x 1 ml titrated control

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

Rubagen 100 TESTS - 08426950590569 Catalog Number :

Device Description : 1 x 1.7 ml LATEX REAGENT1 x 1.0 ml HIGH POSITIVE CONTROL1 x 1.0 ml LOW POSITIVE 1 x 1.7 ml LATEX REAGENT1 x 1.0 ml HIGH POSITIVE CONTROL1 x 1.0 ml LOW POSITIVE CONTROL1 x 1.0 ml NEGATIVE CONTROL1 x 35 ml DILUENT BUFFER8 disposable slides120 plastic stirrers

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : LQN

Prescription Use : Yes

Device Count : 1

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