FUJIREBIO DIAGNOSTICS, INC.

FUJIREBIO DIAGNOSTICS, INC.

Address:201 Great Valley Parkway,Malvern,PA,19355,US

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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

Antigens, Ha, Treponema Pallidum (GMT) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (1) System, Test, Automated Blood Grouping And Antibody (KSZ) (1) Test,Donor,Cmv (MZE) (1) Multi-Analyte Controls Unassayed (OHQ) (1) Antiserum, Fluorescent, Rabies Virus (GOI) (1)

Premarket Exempt

No Yes

Clear

FITC Anti-Rabies Monoclonal Globulin - 00850212007003 Catalog Number :

Device Class : 2

Duns Number: 079291908

Premarket Exempt : No

Product Code : GOI

Prescription Use : Yes

Device Count : 1

Serodia TP-PA - 00850212007010 Catalog Number :

Device Description : 100 test kit

Device Class : 2

Duns Number: 079291908

Premarket Exempt : No

Product Code : GMT

Prescription Use : Yes

Device Count : 1

Serodia TP-PA - 00850212007027 Catalog Number :

Device Description : 220 test kit

Device Class : 2

Duns Number: 079291908

Premarket Exempt : No

Product Code : GMT

Prescription Use : Yes

Device Count : 1

Vitamin D Control - 00850212007034 Catalog Number :

Device Class : 1

Duns Number: 079291908

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Beckman Coulter PK TP System Control Set - 00850212007041 Catalog Number :

Device Class : 2

Duns Number: 079291908

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

Beckman Coulter PK CMV-PA SYSTEM Control Set - 00850212007058 Catalog Number : PA2302

Device Class : 2

Duns Number: 079291908

Premarket Exempt : No

Product Code : MZE

Prescription Use : Yes

Device Count : 1

Syphilis Control - 00850212007065 Catalog Number :

Device Class : 1

Duns Number: 079291908

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

Fertility Control - 00850212007072 Catalog Number :

Device Class :

Duns Number: 079291908

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Vitamin D Control - 00850212007089 Catalog Number :

Device Class : 1

Duns Number: 079291908

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Lumipulse G Wash Solution - 00850212007096 Catalog Number :

Device Description : Lumipulse G Wash Solution

Device Class : 1

Duns Number: 079291908

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

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