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

ihc DAB 1:1 Kit - 00850000596405 Catalog Number : K50002-015

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihc DAB 1:1 Kit - 00850000596412 Catalog Number : K50002-030

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® Cytokeratin 20 Ab - 00850000596429 Catalog Number : K32032-005

Device Description : Clone R1001

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® Cytokeratin 20 Ab - 00850000596436 Catalog Number : K32032-015

Device Description : Clone R1001

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® Cytokeratin 19 Ab - 00850000596443 Catalog Number : K32033-005

Device Description : Clone R1002

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® Cytokeratin 19 Ab - 00850000596450 Catalog Number : K32033-015

Device Description : Clone R1002

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® Mart-1 Ab-Blk - 00850000596467 Catalog Number : K46009-030

Device Description : Clone A103

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® SOX10 Ab-Enh, 5mL - 00850000596474 Catalog Number : K47040-005

Device Description : Clone R1008

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® SOX10 Ab-Enh, 15mL - 00850000596481 Catalog Number : K47040-015

Device Description : Clone R1008

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

ihcDirect® SOX10 Ab, 5mL - 00850000596498 Catalog Number : K32040-005

Device Description : Clone R1008

Device Class : 1

Duns Number: 965326957

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

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