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

Ldl & Vldl Precipitation, Hdl (LBR) (4) Calibrator, Primary (JIS) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment (NSF) (1)

Premarket Exempt

No Yes

Clear

uTASWako DCP Control L - 14987481164489 Catalog Number : 995-61301

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 4

uTASWako DCP Control H - 14987481164496 Catalog Number : 991-61401

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 4

uTASWako Wash Solution - 14987481164502 Catalog Number : 991-60801

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : NSF

Prescription Use : Yes

Device Count : 4

L-Type LDL-C Reagent 1 - 14987481164533 Catalog Number : 999-00404

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : No

Product Code : LBR

Prescription Use : Yes

Device Count : 2

L-Type LDL-C Reagent 2 - 14987481164540 Catalog Number : 999-00504

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : No

Product Code : LBR

Prescription Use : Yes

Device Count : 2

HDL-C/LDL-C Calibrator - 14987481164557 Catalog Number : 990-28011

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 4

L-Type HDL-C Reagent 1 - 14987481164564 Catalog Number : 991-00101

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 4

L-Type HDL-C Reagent 2 - 14987481164571 Catalog Number : 997-00201

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 4

L-Type HDL-C Reagent 1 - 14987481164588 Catalog Number : 997-72591

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : No

Product Code : LBR

Prescription Use : Yes

Device Count : 4

L-Type HDL-C Reagent 2 - 14987481164595 Catalog Number : 993-72691

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : No

Product Code : LBR

Prescription Use : Yes

Device Count : 4

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