NIPPON KAYAKU CO., LTD.

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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, 1,5-Anhydroglucitol (15ag) (NOZ) (1) Calibrator, Primary (JIS) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

Clear

GLYCOMARK - 04987170775562 Catalog Number :

Device Description : Kit Reagents1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control

Device Class : 2

Duns Number: 690547468

Premarket Exempt : No

Product Code : NOZ

Prescription Use : Yes

Device Count : 1

GLYCOMARK - 04987170775579 Catalog Number :

Device Description : Calibration Standard1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glyc

Device Class : 2

Duns Number: 690547468

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 1

GLYCOMARK - 04987170775586 Catalog Number :

Device Description : Controls1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control

Device Class : 1

Duns Number: 690547468

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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