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® - 00615233000637 Catalog Number : 8253-M250

Device Description : anti-CD10 Mouse Monoclonal Antibody [GM003], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000644 Catalog Number : 8253-C010

Device Description : anti-CD10 Mouse Monoclonal Antibody [GM003], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000651 Catalog Number : 8255-C010

Device Description : anti-CD2 Rabbit Monoclonal Antibody [EP222], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000668 Catalog Number : 8255-M250

Device Description : anti-CD2 Rabbit Monoclonal Antibody [EP222], 1 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000675 Catalog Number : 8256-C010

Device Description : anti-CD15 Rabbit Monoclonal Antibody [EP273], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000682 Catalog Number : 8256-M250

Device Description : anti-CD15 Rabbit Monoclonal Antibody [EP273], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000699 Catalog Number : 8259-M250

Device Description : anti-CD20 Mouse Monoclonal Antibody [L26], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000705 Catalog Number : 8259-C010

Device Description : anti-CD20 Mouse Monoclonal Antibody [L26], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000712 Catalog Number : 8260-C010

Device Description : anti-CD21 Rabbit Monoclonal Antibody [EP64], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000729 Catalog Number : 8260-M250

Device Description : anti-CD21 Rabbit Monoclonal Antibody [EP64], 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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