DIAGNOSTICA STAGO

Address:5 Century Dr,PARSIPPANY,NJ,07054,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

General purpose reagent (PPM) (3) REAGENT, RUSSEL VIPER VENOM (GIR) (3) FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL (DAP) (2) ACTIVATED PARTIAL THROMBOPLASTIN (GFO) (1) PLASMA, COAGULATION FACTOR DEFICIENT (GJT) (1)

Premarket Exempt

No Yes

Clear

STA® - Cephascreen® 10 - 13607450003106 Catalog Number :

Device Class :

Duns Number: 262277122

Premarket Exempt : No

Product Code : GFO

Prescription Use : Yes

Device Count : 12

STA® - Staclot® dRVV Screen 5 - 13607450003335 Catalog Number :

Device Class :

Duns Number: 262277122

Premarket Exempt : No

Product Code : GIR

Prescription Use : Yes

Device Count : 12

STA® - Staclot® dRVV Confirm - 13607450003342 Catalog Number :

Device Class :

Duns Number: 262277122

Premarket Exempt : No

Product Code : GIR

Prescription Use : Yes

Device Count : 12

STA® - Staclot® dRVV Screen 2 - 13607450003397 Catalog Number :

Device Class :

Duns Number: 262277122

Premarket Exempt : No

Product Code : GIR

Prescription Use : Yes

Device Count : 12

STA® - Owren-Koller - 13607450003601 Catalog Number :

Device Class :

Duns Number: 262277122

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 24

STA® - CaCl2 0.025 M - 13607450003670 Catalog Number :

Device Class :

Duns Number: 262277122

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 24

STA® - VWF:Ag Calibrator - 13607450005209 Catalog Number :

Device Class :

Duns Number: 262277122

Premarket Exempt : No

Product Code : GJT

Prescription Use : Yes

Device Count : 6

FDP Plasma (Latex) - 13607450005414 Catalog Number :

Device Class :

Duns Number: 262277122

Premarket Exempt : No

Product Code : DAP

Prescription Use : Yes

Device Count : 12

FDP Plasma (Buffer) - 13607450005513 Catalog Number :

Device Class :

Duns Number: 262277122

Premarket Exempt : No

Product Code : DAP

Prescription Use : Yes

Device Count : 12

Asserachrom® Washing Solution - 13607450005551 Catalog Number :

Device Class :

Duns Number: 262277122

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 2

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