HYPHEN BIOMED

Address:155 RUE D ERAGNY,NEUVILLE SUR OISE Val-d'Oise,FR

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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

Plasma, Coagulation Control (GGN) (2) Platelet Factor 4 Radioimmunoassay (LCO) (2)

Premarket Exempt

No Yes

Clear

BIOPHEN LMWH CONTROL LOW CII - 03663537043512 Catalog Number : 224401

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 1

BIOPHEN LMWH Control C4 - 03663537043550 Catalog Number : 224201

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 1

ZYMUTEST HIA MonoStrip IgG - 03663537046803 Catalog Number : RK041A

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : LCO

Prescription Use : No

Device Count : 1

ZYMUTEST HIA MonoStrip IgGAM - 03663537046810 Catalog Number : RK041D

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : LCO

Prescription Use : No

Device Count : 1

Calcium chloride 0.025M (M/40) - 03663537084768 Catalog Number : AR001B

Device Class :

Duns Number: 503499167

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Calcium chloride 0.025M (M/40) - 03663537084782 Catalog Number : AR001L

Device Class :

Duns Number: 503499167

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Imidazole buffer - 03663537084805 Catalog Number :

Device Class :

Duns Number: 503499167

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Imidazole buffer - 03663537084829 Catalog Number :

Device Class :

Duns Number: 503499167

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Imidazole buffer - 03663537084843 Catalog Number :

Device Class :

Duns Number: 503499167

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

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