SAKURA FINETEK U.S.A., INC.

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

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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® - 00615233000439 Catalog Number : 8233-M250

Device Description : anti-Epithelial Membrane Antigen Mouse Monoclonal Antibody [E29], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000446 Catalog Number : 8233-C010

Device Description : anti-Epithelial Membrane Antigen Mouse Monoclonal Antibody [E29], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000453 Catalog Number : 8238-C010

Device Description : anti-Cytokeratin LMW (CK8) Rabbit Monoclonal Antibody [EP17], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000460 Catalog Number : 8238-M250

Device Description : anti-Cytokeratin LMW (CK8) Rabbit Monoclonal Antibody [EP17], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000477 Catalog Number : 8241-M250

Device Description : anti-CD138 Mouse Monoclonal Antibody [B-A38], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000484 Catalog Number : 8241-C010

Device Description : anti-CD138 Mouse Monoclonal Antibody [B-A38], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000491 Catalog Number : 8242-C010

Device Description : anti-GATA3 Rabbit Monoclonal Antibody [EP368], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000507 Catalog Number : 8242-M250

Device Description : anti-GATA3 Rabbit Monoclonal Antibody [EP368], 1 cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000514 Catalog Number : 8243-M250

Device Description : anti-Terminal Deoxyribonucleotidyl Transferase Mouse Monoclonal Antibody [SEN28] anti-Terminal Deoxyribonucleotidyl Transferase Mouse Monoclonal Antibody [SEN28], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000521 Catalog Number : 8243-C010

Device Description : anti-Terminal Deoxyribonucleotidyl Transferase Mouse Monoclonal Antibody [SEN28] anti-Terminal Deoxyribonucleotidyl Transferase Mouse Monoclonal Antibody [SEN28], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

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