R 2 DIAGNOSTICS, INC.

R 2 DIAGNOSTICS, INC.

Address:1801 COMMERCE DR.,SOUTH BEND,IN,46628,US

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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

Control, Plasma, Abnormal (GGC) (4) Plasma, Control, Normal (GIZ) (3) Test, Time, Prothrombin (GJS) (2) System, Fibrinogen Determination (KQJ) (1) Test, Fibrinogen (GIS) (1) Test, Qualitative And Quantitative Factor Deficiency (GGP) (1) Test, Thrombin Time (GJA) (1) Test, Time, Partial Thromboplastin (GGW) (1) Reagent, Russel Viper Venom (GIR) (1)

Premarket Exempt

No Yes

Clear

Fibrotek - 00859394006040 Catalog Number : 70-410

Device Description : Fibrinogen assay 100 DET

Device Class : 2

Duns Number: 956610125

Premarket Exempt : No

Product Code : KQJ, GIS

Prescription Use : No

Device Count : 1

ThromboTek PSe - 00859394006095 Catalog Number : 90-480

Device Description : Protein S Kit 80-160 DET

Device Class : 2

Duns Number: 956610125

Premarket Exempt : No

Product Code : GGP

Prescription Use : No

Device Count : 1

Phospholin ES w/ Calcium Chloride - 10859394006016 Catalog Number : 21-410

Device Description : APTT reagent 5 x 10 ml with 5 Calcium Chloride

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GGW

Prescription Use : No

Device Count : 5

Phosphoplastin RL - 10859394006023 Catalog Number : 11-305

Device Description : PT reagent 10 x 5 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GJS

Prescription Use : No

Device Count : 10

Phosphoplastin RL - 10859394006030 Catalog Number : 11-310

Device Description : PT reagent 10 x 10 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GJS

Prescription Use : No

Device Count : 10

T-tek - 10859394006054 Catalog Number : 50-201

Device Description : Thrombin Time 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GJA

Prescription Use : No

Device Count : 10

PlasmaCon N - 10859394006061 Catalog Number : 30-201

Device Description : Normal Control 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GGC, GIZ

Prescription Use : No

Device Count : 10

PlasmaCon L1 - 10859394006078 Catalog Number : 31-201

Device Description : Abnormal Control L-1 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GGC, GIZ

Prescription Use : No

Device Count : 10

PlasmaCon L2 - 10859394006085 Catalog Number : 32-201

Device Description : Abnormal Control L-2 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GGC, GIZ

Prescription Use : No

Device Count : 10

LupoTek Detectin VL - 10859394006108 Catalog Number : 85-202

Device Description : Venom Screening test of LA 10 x 2 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GIR, GGC

Prescription Use : No

Device Count : 10

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