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® - 00615233000835 Catalog Number : 8268-C010

Device Description : anti-CD34 Mouse Monoclonal Antibody [QBEnd/10], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000842 Catalog Number : 8268-M250

Device Description : anti-CD34 Mouse Monoclonal Antibody [QBEnd/10], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000859 Catalog Number : 8271-M250

Device Description : anti-CD45 Rabbit Monoclonal Antibody [GR009], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000866 Catalog Number : 8271-C010

Device Description : anti-CD45 Rabbit Monoclonal Antibody [GR009], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000873 Catalog Number : 8272-C010

Device Description : anti-CD45RO Mouse Monoclonal Antibody [UCHL1], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000880 Catalog Number : 8272-M250

Device Description : anti-CD45RO Mouse Monoclonal Antibody [UCHL1], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000897 Catalog Number : 8274-M250

Device Description : anti-CD56 Rabbit Monoclonal Antibody [MRQ-42], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000903 Catalog Number : 8274-C010

Device Description : anti-CD56 Rabbit Monoclonal Antibody [MRQ-42], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000910 Catalog Number : 8275-C010

Device Description : anti-CD68 Rabbit Monoclonal Antibody [GR021], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000927 Catalog Number : 8275-M250

Device Description : anti-CD68 Rabbit Monoclonal Antibody [GR021], 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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