BIOKIT, S.A.

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

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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

Latex Agglutination Assay, Rubella (LQN) (2) Antigens, Nontreponemal, All (GMQ) (1) Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (LGC) (1) System, Multipurpose For In Vitro Coagulation Studies (JPA) (1) System, Test, Rheumatoid Factor (DHR) (1)

Premarket Exempt

No Yes

Clear

Rubajet 100 TESTS - 08426950590576 Catalog Number :

Device Description : 1 x 1.7 ml LATEX REAGENT1 x 1.5 ml HIGH POSITIVE CONTROL1 x 1.5 ml LOW POSITIVE 1 x 1.7 ml LATEX REAGENT1 x 1.5 ml HIGH POSITIVE CONTROL1 x 1.5 ml LOW POSITIVE CONTROL1 x 15 ml DILUENT BUFFER13 disposable slides

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : LQN

Prescription Use : Yes

Device Count : 1

Rubajet 500 TESTS - 08426950590583 Catalog Number :

Device Description : 5 x 1.7 ml LATEX REAGENT2 x 1.5 ml HIGH POSITIVE CONTROL2 x 1.5 ml LOW POSITIVE 5 x 1.7 ml LATEX REAGENT2 x 1.5 ml HIGH POSITIVE CONTROL2 x 1.5 ml LOW POSITIVE CONTROL2 x 15 ml DILUENT BUFFER45 disposable slides

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : LQN

Prescription Use : Yes

Device Count : 1

Rheumajet RF 50 TESTS - 08426950590613 Catalog Number :

Device Description : 1 x 2.5 ml REAGENT1 x 1.0 ml CONTROL +1 x 1.0 ml CONTROL –1 x 9 SLIDES

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

Biokit RPR 500 TESTS - 08426950592327 Catalog Number :

Device Description : 3 x 3.0 ml RPR ANTIGEN1 x 1.5 ml REACTIVE CONTROL1 x 1.5 ml MODERATE REACTIVE CO 3 x 3.0 ml RPR ANTIGEN1 x 1.5 ml REACTIVE CONTROL1 x 1.5 ml MODERATE REACTIVE CONTROL1 x 1.5 ml NONREACTIVE CONTROL50 disposable cards500 dispensing / spreading pipettes1 antigen dispensing vial1 antigen dispensing needle

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 1

BIO-FLASH - 08426950639725 Catalog Number :

Device Description : BIO-FLASH

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : JPA

Prescription Use : Yes

Device Count : 1

biokitHSV-2 - 08426951056439 Catalog Number :

Device Description : 20 Test Devices20 x 0,7 ml Sample Diluent20 x 0,5 ml Developing Reagent20 x Empt 20 Test Devices20 x 0,7 ml Sample Diluent20 x 0,5 ml Developing Reagent20 x Empty Vials 120 x Pre-filter tips20 x Capillary tubes20 x Lancets20 x Swabs20 x Tube racks

Device Class : 2

Duns Number: 460055742

Premarket Exempt : No

Product Code : LGC

Prescription Use : Yes

Device Count : 1

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