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) (3) Reagent, Russel Viper Venom (GIR) (3) Plasma, Coagulation Control (GGN) (2) Plasma, Coagulation Factor Deficient (GJT) (2) Test, Time, Partial Thromboplastin (GGW) (2) Test, Fibrinogen (GIS) (1)

Premarket Exempt

No Yes

Clear

LupoTek Correctin VL - 10859394006115 Catalog Number : 86-201

Device Description : Venom Confirmatory test for LA 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GIR, GGC

Prescription Use : No

Device Count : 10

PlasmaCon LA - 10859394006122 Catalog Number : 150-200

Device Description : Positive control for LA 10 x 0.5 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GGC, GIR

Prescription Use : No

Device Count : 10

PlasmaCon LA - 10859394006139 Catalog Number : 150-201

Device Description : Positive control for LA 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GGC, GIR

Prescription Use : No

Device Count : 10

LupoTek KCT - 10859394006146 Catalog Number : 87-305

Device Description : Screening test for LA 250 DET

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GGW

Prescription Use : No

Device Count : 5

NoFact VIII - 10859394006153 Catalog Number : 68-201

Device Description : Factor VIII immunodepleted 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GJT

Prescription Use : No

Device Count : 10

NoFact IX - 10859394006160 Catalog Number : 69-201

Device Description : Factor IX immunodepleted 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GJT

Prescription Use : No

Device Count : 10

PlasmaRef ARN - 10859394006177 Catalog Number : 33-201

Device Description : Assayed Reference Plasma 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : No

Device Count : 10

PlasmaRef ARL-2 - 10859394006184 Catalog Number : 35-201

Device Description : Assayed Reference Plasma L-2 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : No

Device Count : 10

FIB Calibrator - 10859394006191 Catalog Number : 71-201

Device Description : Fibrinogen Reference Plasma 10 x 1 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GIS

Prescription Use : No

Device Count : 10

Phospholin ES w/Calcium - 10859394006238 Catalog Number : 21-405

Device Description : APTT reagent 5 x 5 ml

Device Class :

Duns Number: 956610125

Premarket Exempt : No

Product Code : GGW

Prescription Use : No

Device Count : 5

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