FUJIFILM WAKO PURE CHEMICAL CORPORATION

Address:2613-2 Oaza Ogohara,Komono-Cho Mie,JP

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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

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (3) Calibrator, Primary (JIS) (2) Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment (NSF) (2) Calibrator, Multi-Analyte Mixture (JIX) (1) Calibrator, Secondary (JIT) (1) Ldl & Vldl Precipitation, Hdl (LBR) (1)

Premarket Exempt

No Yes

Clear

NEFA Standard Solution - 10856626006011 Catalog Number : 276-76491

Device Description : In-Vitro Diagnostic Use

Device Class :

Duns Number: 690598875

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 4

Multi Calibrator Lipids - 10856626006028 Catalog Number : 464-01601

Device Description : In-Vitro Diagnostic Use

Device Class :

Duns Number: 690598875

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 4

HDL-C/LDL-C Calibrator - 10856626006035 Catalog Number : 990-28011

Device Description : In-Vitro Diagnostic Use

Device Class :

Duns Number: 690598875

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 4

L-Type HDL-C (Reagent 1) - 10856626006042 Catalog Number : 991-00101

Device Description : The L-Type HDL-C is an in vitro assay for the quantitative determination of high The L-Type HDL-C is an in vitro assay for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in serum. (4 each 600 mL)

Device Class :

Duns Number: 690598875

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 4

uTASWako Wash Solution - 10856626006059 Catalog Number : 991-60801

Device Description : In-Vitro Diagnostic Use

Device Class :

Duns Number: 690598875

Premarket Exempt : No

Product Code : NSF

Prescription Use : Yes

Device Count : 4

uTASWako DCP Control H - 10856626006066 Catalog Number : 991-61401

Device Description : In-Vitro Diagnostic Use

Device Class :

Duns Number: 690598875

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 4

uTASWako AFP-L3 Control H - 10856626006073 Catalog Number : 993-61101

Device Description : In-Vitro Diagnostic Use

Device Class :

Duns Number: 690598875

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 4

uTASWako Chip Cassette - 10856626006080 Catalog Number : 993-61601

Device Description : The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30.

Device Class :

Duns Number: 690598875

Premarket Exempt : No

Product Code : NSF

Prescription Use : Yes

Device Count : 5

L-Type HDL-C Reagent 2 - 10856626006097 Catalog Number : 993-72691

Device Description : In-Vitro Diagnostic Use

Device Class :

Duns Number: 690598875

Premarket Exempt : No

Product Code : LBR

Prescription Use : Yes

Device Count : 4

uTASWako DCP Control L - 10856626006134 Catalog Number : 995-61301

Device Description : In-Vitro Diagnostic Use

Device Class :

Duns Number: 690598875

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 4

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