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

Calibrators, Drug Specific (DLJ) (3) Drug Specific Control Materials (LAS) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Enzyme Immunoassay, Opiates (DJG) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Gas Chromatography, Methamphetamine (LAF) (1)

Premarket Exempt

No Yes

Clear

CEDIA Amphetamine OFT Assay - 00884883000209 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DKZ

Prescription Use : No

Device Count : 1

CEDIA Cannabinoids OFT Assay - 00884883000216 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : LDJ

Prescription Use : No

Device Count : 1

CEDIA Cocaine OFT Assay - 00884883000223 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DIO

Prescription Use : No

Device Count : 1

CEDIA Methamphetamine OFT Assay - 00884883000230 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : LAF

Prescription Use : No

Device Count : 1

CEDIA Opiate OFT Assay - 00884883000247 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

CEDIA Phencyclidine (PCP) OFT Assay - 00884883000254 Catalog Number :

Device Class : U

Duns Number: 122153799

Premarket Exempt : No

Product Code : LCM

Prescription Use : No

Device Count : 1

DRI Hydrocodone Controls - 00884883000360 Catalog Number :

Device Class : 1

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DRI Hydrocodone Calibrator 100 - 00884883000377 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DLJ

Prescription Use : No

Device Count : 1

DRI Hydrocodone Calibrator 300 - 00884883000384 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DLJ

Prescription Use : No

Device Count : 1

DRI Hydrocodone Calibrator 500 - 00884883000391 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DLJ

Prescription Use : No

Device Count : 1

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