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) (8) SLIDES, MICROSCOPE (KEW) (2)

Premarket Exempt

Yes

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Tissue-Tek® SmartWrite® - 00615233000323 Catalog Number : 9054

Device Description : Yellow Frosted Slides - Charged

Device Class :

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : KEW

Prescription Use : No

Device Count : 10

Tissue-Tek® SmartWrite® - 00615233000347 Catalog Number : 9036

Device Description : White Frosted Slides - Charged

Device Class :

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : KEW

Prescription Use : No

Device Count : 10

Tissue-Tek Genie® - 00615233000354 Catalog Number : 8223-M250

Device Description : anti-Calretinin Rabbit Polyclonal Antibody, 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000361 Catalog Number : 8223-C010

Device Description : anti-Calretinin Rabbit Polyclonal Antibody, 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000378 Catalog Number : 8224-C010

Device Description : anti-Thyroid Transcription Factor-1 Rabbit Monoclonal Antibody [EP229], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000385 Catalog Number : 8224-M250

Device Description : anti-Thyroid Transcription Factor-1 Rabbit Monoclonal Antibody [EP229], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000392 Catalog Number : 8230-M250

Device Description : anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [VU-1D9], 1 RTU cartridge

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000408 Catalog Number : 8230-C010

Device Description : anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [VU-1D9], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000415 Catalog Number : 8232-C010

Device Description : anti-Melanosome Mouse Monoclonal Antibody [HMB45], 10 RTU capsules

Device Class : 1

Duns Number: 179135769

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Tissue-Tek Genie® - 00615233000422 Catalog Number : 8232-M250

Device Description : anti-Melanosome Mouse Monoclonal Antibody [HMB45], 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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