SAKURA FINETEK U.S.A., INC.

Address:1750 W 214th St,TORRANCE,CA,90501,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

Yes

Clear

Tissue-Tek Genie® - 00615233000538 Catalog Number : 8245-C010

Device Description : anti-CD163 Rabbit Monoclonal Antibody [EP324], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000545 Catalog Number : 8245-M250

Device Description : anti-CD163 Rabbit Monoclonal Antibody [EP324], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000552 Catalog Number : 8246-M250

Device Description : anti-CD1a Rabbit Monoclonal Antibody [EP80], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000569 Catalog Number : 8246-C010

Device Description : anti-CD1a Rabbit Monoclonal Antibody [EP80], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000576 Catalog Number : 8249-C010

Device Description : anti-CD5 Rabbit Monoclonal Antibody [GR020], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000583 Catalog Number : 8249-M250

Device Description : anti-CD5 Rabbit Monoclonal Antibody [GR020], 1 RTU cartridges

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000590 Catalog Number : 8251-M250

Device Description : anti-CD7 Rabbit Monoclonal Antibody [EP132], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000606 Catalog Number : 8251-C010

Device Description : anti-CD7 Rabbit Monoclonal Antibody [EP132], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000613 Catalog Number : 8252-C010

Device Description : anti-CD8 Mouse Monoclonal Antibody [C8/144B], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000620 Catalog Number : 8252-M250

Device Description : anti-CD8 Mouse Monoclonal Antibody [C8/144B], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

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