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

TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY (GGP) (5) Fibrin monomer paracoagulation (JBN) (2) ASSAY, HEPARIN (KFF) (1) CONVERSION TO CREATININE, CREATINE (JLA) (1) PLASMA, COAGULATION CONTROL (GGN) (1)

Premarket Exempt

No Yes

Clear

STA® - Quality HBPM/LMWH - 03607450006865 Catalog Number :

Device Class : 2

Duns Number: 262277122

Premarket Exempt : No

Product Code : GGN

Prescription Use : Yes

Device Count : 1

STA® - Staclot® Protein C 3 - 03607450007374 Catalog Number :

Device Class : 2

Duns Number: 262277122

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

STA® - Staclot® Protein S - 03607450007466 Catalog Number :

Device Class : 2

Duns Number: 262277122

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

STA® - Staclot® Protein C 1 - 03607450007473 Catalog Number :

Device Class : 2

Duns Number: 262277122

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

F.S. Test - 03607450008579 Catalog Number :

Device Class : 2

Duns Number: 262277122

Premarket Exempt : No

Product Code : JBN

Prescription Use : Yes

Device Count : 1

F.S. Test Unit - 03607450008876 Catalog Number :

Device Class : 2

Duns Number: 262277122

Premarket Exempt : No

Product Code : JBN

Prescription Use : Yes

Device Count : 1

Stachrom® Heparin - 03607450009064 Catalog Number :

Device Class : 2

Duns Number: 262277122

Premarket Exempt : No

Product Code : KFF

Prescription Use : Yes

Device Count : 1

Asserachrom® VWF:Ag - 03607450009422 Catalog Number :

Device Class : 2

Duns Number: 262277122

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

Asserachrom® IX:Ag - 03607450009439 Catalog Number :

Device Class : 2

Duns Number: 262277122

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

Asserachrom® Protein C - 03607450009446 Catalog Number :

Device Class : 1

Duns Number: 262277122

Premarket Exempt : No

Product Code : JLA

Prescription Use : Yes

Device Count : 1

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