TOSOH BIOSCIENCE, INC.

Address:3600 Gantz Rd,Grove City,OH,43123,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

Assay, Glycosylated Hemoglobin (LCP) (3) Products, Red-Cell Lysing Products (GGK) (1)

Premarket Exempt

Yes

Clear

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R - 00853931008009 Catalog Number : 021560R

Device Description : Glycated Hemoglobin (HbA1C) Analyzer IVD

Device Class : 2

Duns Number: 607696440

Premarket Exempt : Yes

Product Code : LCP

Prescription Use : No

Device Count : 1

Glycated Hemoglobin (HbA1C) Analyzer IVD - 00853931008016 Catalog Number : 021561R

Device Description : Glycated hemoglobin (HbA1C) analyzer IVD, 90 Sample Loader, Remanufactured

Device Class : 2

Duns Number: 607696440

Premarket Exempt : Yes

Product Code : LCP

Prescription Use : No

Device Count : 1

Glycated Hemoglobin (HbA1C) Analyser IVD, 290 Loader, Remanufactured - 00853931008023 Catalog Number : 021562R

Device Description : Glycated hemoglobin (HbA1C) analyzer IVD, 290 Sample Loader, Remanufactured

Device Class : 2

Duns Number: 607696440

Premarket Exempt : Yes

Product Code : LCP

Prescription Use : No

Device Count : 1

Hemolysis and Wash Solution - 00853931008030 Catalog Number :

Device Description : Red Cell Lysing Reagent

Device Class : 1

Duns Number: 607696440

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : Yes

Device Count : 1

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