FUJIREBIO INC.

Address:1-3-14 Tanashioda, Chuo-ku,Sagamihara Kanagawa,JP

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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

Calibrator, Secondary (JIT) (2) Procalcitonin Assay (PRI) (2) Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens (PMT) (2) Antigen, Inflammatory Response Marker, Sepsis (NTM) (2) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (1) Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) (LTK) (1) Diluent, Blood Cell (GIF) (1) Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (LIP) (1) Test, Epithelial Ovarian Tumor Associated Antigen (He4) (OIU) (1)

Premarket Exempt

Yes No

Clear

Lumipulse G BRAHMS PCT Calibrator Set - 04987270234150 Catalog Number :

Device Class : 2

Duns Number: 710873907

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

Lumipulse BRAHMS PCT Controls - 04987270234167 Catalog Number :

Device Class : 2

Duns Number: 710873907

Premarket Exempt : No

Product Code : NTM, PMT, PRI

Prescription Use : Yes

Device Count : 1

Lumipulse G HE4 Immunoreaction Cartridges - 04987270234174 Catalog Number :

Device Class : 2

Duns Number: 710873907

Premarket Exempt : No

Product Code : OIU

Prescription Use : Yes

Device Count : 1

Lumipulse G HE4 Calibrators - 04987270234181 Catalog Number :

Device Class : 2

Duns Number: 710873907

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

LUMIPULSE G1200 - 04987270234259 Catalog Number :

Device Class : 1

Duns Number: 710873907

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Lumipulse G CA125II Immunoreaction Cartridges - 04987270234273 Catalog Number :

Device Class : 2

Duns Number: 710873907

Premarket Exempt : No

Product Code : LTK

Prescription Use : Yes

Device Count : 1

Soda Lime for LUMIPULSE System - 04987270234440 Catalog Number :

Device Class :

Duns Number: 710873907

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Lumipulse G Specimen Diluent 6 - 04987270234693 Catalog Number :

Device Class : 1

Duns Number: 710873907

Premarket Exempt : No

Product Code : GIF

Prescription Use : Yes

Device Count : 1

Lumipulse G TP-N Immunoreaction Cartridges Set - 04987270235041 Catalog Number :

Device Class : 2

Duns Number: 710873907

Premarket Exempt : No

Product Code : LIP

Prescription Use : Yes

Device Count : 1

Lumipulse G BRAHMS PCT Immunoreaction Cartridges - 04987270235058 Catalog Number :

Device Class : 2

Duns Number: 710873907

Premarket Exempt : No

Product Code : NTM, PMT, PRI

Prescription Use : Yes

Device Count : 1

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