FUJIFILM WAKO PURE CHEMICAL CORPORATION

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

Complement C9, Antigen, Antiserum, Control (DAE) (3) Calibrator, Secondary (JIT) (2) Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment (NSF) (2) Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma (OAU) (1) Micro Total Analysis Instrument System (OUE) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

Autokit Micro Albumin Calibrator Set - 00856626006106 Catalog Number : 995-06101

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Autokit CH50 - 00856626006113 Catalog Number : 995-40801

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : DAE

Prescription Use : Yes

Device Count : 1

uTASWako DCP - 00856626006120 Catalog Number : 995-60701

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : OAU

Prescription Use : Yes

Device Count : 1

CH50 Calibrator - 00856626006151 Catalog Number : 997-43801

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : DAE

Prescription Use : Yes

Device Count : 1

uTASWako AFP-L3 Calibrator Set - 00856626006168 Catalog Number : 997-60901

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

uTASWako AFP-L3 - 00856626006205 Catalog Number : 999-60601

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : NSF

Prescription Use : Yes

Device Count : 1

uTASWako DCP Calibrator Set - 00856626006212 Catalog Number : 999-61201

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

uTASWako i30 - 00856626006229 Catalog Number : 991-60301

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : OUE

Prescription Use : Yes

Device Count : 1

uTASWako AFP-L3 - 04987481164390 Catalog Number : 999-60601

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : NSF

Prescription Use : Yes

Device Count : 1

Autokit CH50 - 04987481164406 Catalog Number : 995-40801

Device Description : In-Vitro Diagnostic Use

Device Class : 2

Duns Number: 690598875

Premarket Exempt : No

Product Code : DAE

Prescription Use : Yes

Device Count : 1

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