HORIBA ABX SAS

Address:PARC EUROMEDECINE,MONTPELLIER Herault,FR

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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

Calibrator, Multi-Analyte Mixture (JIX) (2) Calibrator, Primary (JIS) (1) Ferritin, Antigen, Antiserum, Control (DBF) (1) Iga, Antigen, Antiserum, Control (CZP) (1) Igg, Antigen, Antiserum, Control (DEW) (1) Igm, Antigen, Antiserum, Control (DFT) (1) Prealbumin, Antigen, Antiserum, Control (JZJ) (1) System, Test, Rheumatoid Factor (DHR) (1) Transferrin, Antigen, Antiserum, Control (DDG) (1)

Premarket Exempt

No Yes

Clear

Yumizen C1200 Ferritin - 03610230007327 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : DBF

Prescription Use : No

Device Count : 1

Yumizen C1200 Immunoglobulin A - 03610230007334 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : CZP

Prescription Use : No

Device Count : 1

Yumizen C1200 Immunoglobulin G - 03610230007358 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : DEW

Prescription Use : No

Device Count : 1

Yumizen C1200 Immunoglobulin M - 03610230007365 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : DFT

Prescription Use : No

Device Count : 1

Yumizen C1200 Prealbumin - 03610230007396 Catalog Number :

Device Class : 1

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : JZJ

Prescription Use : No

Device Count : 1

Yumizen C1200 Rheumatoid Factor - 03610230007402 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : DHR

Prescription Use : No

Device Count : 1

Yumizen C1200 Transferrin - 03610230007419 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : No

Product Code : DDG

Prescription Use : No

Device Count : 1

Yumizen C1200 Multi Cal - 03610230007426 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

Yumizen C1200 Protein Cal - 03610230007457 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

Yumizen C1200 Micro Alb U/CSF Cal Normal - 03610230007464 Catalog Number :

Device Class : 2

Duns Number: 273647420

Premarket Exempt : Yes

Product Code : JIS

Prescription Use : No

Device Count : 1

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