Microgenics Corporation

Address:46500 Kato Road,Fremont,CA,94538,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

Calibrator, Multi-Analyte Mixture (JIX) (2) Calibrator, Primary (JIS) (1) Enzyme Immunoassay, Carbamazepine (KLT) (1) Enzyme Immunoassay, Digoxin (KXT) (1) Enzyme Immunoassay, Diphenylhydantoin (DIP) (1) Enzyme Immunoassay, Gentamicin (LCD) (1) Enzyme Immunoassay, Phenobarbital (DLZ) (1) Enzyme Immunoassay, Theophylline (KLS) (1) Enzyme Immunoassay, Valproic Acid (LEG) (1)

Premarket Exempt

No Yes

Clear

DRI Digoxin Assay - 00884883001206 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : KXT

Prescription Use : No

Device Count : 1

CEDIA Cardiac TDM Multi-Calibrators - 00884883001213 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

CEDIA Phenytoin II Assay - 00884883001220 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DIP

Prescription Use : No

Device Count : 1

CEDIA Phenobarbital II Assay - 00884883001237 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DLZ

Prescription Use : No

Device Count : 1

CEDIA Carbamazepine II Assay - 00884883001251 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : KLT

Prescription Use : No

Device Count : 1

CEDIA Core TDM Multi-Calibrators - 00884883001268 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 1

CEDIA Theophylline II Assay - 00884883001275 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : KLS

Prescription Use : No

Device Count : 1

CEDIA Cyclosporine PLUS High Range Calibrators (450/2000) - 00884883001299 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : JIS

Prescription Use : No

Device Count : 1

CEDIA Valproic Acid II Assay - 00884883001305 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : LEG

Prescription Use : No

Device Count : 1

CEDIA Gentamicin II Assay - 00884883001312 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : LCD

Prescription Use : No

Device Count : 1

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