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

Enzyme Immunoassay, Opiates (DJG) (4) Calibrators, Drug Specific (DLJ) (2) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Everolimus Immunoassay (OUF) (1) Gas Chromatography, Methamphetamine (LAF) (1)

Premarket Exempt

No Yes

Clear

DRI Hydrocodone Calibrator 1000 - 00884883000407 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DLJ

Prescription Use : No

Device Count : 1

DRI Hydrocodone Assay - 00884883000414 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

DRI Hydrocodone Assay - 00884883000421 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

DRI Hydrocodone Assay - 00884883000438 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

QMS Everolimus Immunoassay - 00884883000537 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : OUF

Prescription Use : No

Device Count : 1

QMS Lidocaine Immunoassay - 00884883000704 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DLJ

Prescription Use : No

Device Count : 1

CEDIA Phencyclidine (PCP) OFT Assay - 00884883000803 Catalog Number :

Device Class : U

Duns Number: 122153799

Premarket Exempt : No

Product Code : LCM

Prescription Use : No

Device Count : 1

CEDIA Opiate OFT Assay - 00884883000810 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

CEDIA Methamphetamine OFT Assay - 00884883000827 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : LAF

Prescription Use : No

Device Count : 1

CEDIA Cocaine OFT Assay - 00884883000834 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DIO

Prescription Use : No

Device Count : 1

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