NOVODIAX, INC.

NOVODIAX, INC.

Address:3517 Breakwater Ave,Hayward,CA,94545,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

Immunohistochemistry Reagents And Kits (NJT) (10)

Premarket Exempt

No Yes

Clear

ihcDirect® AE1/AE3 Abs - 00850000596009 Catalog Number : K31007-005

Device Description : Clones AE1/AE3

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® AE1/AE3 Abs - 00850000596016 Catalog Number : K31007-015

Device Description : Clones AE1/AE3

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® Calponin Ab - 00850000596023 Catalog Number : K31026-005

Device Description : Clone C126

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® Calponin Ab - 00850000596030 Catalog Number : K31026-015

Device Description : Clone C126

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® CEA Ab - 00850000596047 Catalog Number : K31038-005

Device Description : Clone C135

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® CEA Ab - 00850000596054 Catalog Number : K31038-015

Device Description : Clone C135

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® CD20 Ab - 00850000596061 Catalog Number : K32029-005

Device Description : Clone R272

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® CD20 Ab - 00850000596078 Catalog Number : K32029-015

Device Description : Clone R272

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® CD45 Ab - 00850000596085 Catalog Number : K31010-005

Device Description : Clone C95

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® CD45 Ab - 00850000596092 Catalog Number : K31010-015

Device Description : Clone C95

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

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