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 Immunoassasy, Nocotine And Nicotine Metabolites (MKU) (4) Alcohol Control Materials (DKC) (2) Calibrators, Drug Mixture (DKB) (1) Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet (DMT) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1)

Premarket Exempt

No Yes

Clear

CEDIA Amphetamine OFT Assay - 00884883000841 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DKZ

Prescription Use : No

Device Count : 1

CEDIA Cannabinoids OFT Assay - 00884883000858 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : LDJ

Prescription Use : No

Device Count : 1

DRI Ethyl Alcohol Assay - 00884883001008 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DMT

Prescription Use : No

Device Count : 1

DRI 50 mg/dL Alcohol Control - 00884883001015 Catalog Number :

Device Class : 1

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : DKC

Prescription Use : No

Device Count : 1

DRI 300 mg/dL Alcohol Control - 00884883001039 Catalog Number :

Device Class : 1

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : DKC

Prescription Use : No

Device Count : 1

DRI Cotinine Assay - 00884883001053 Catalog Number :

Device Class : 1

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : MKU

Prescription Use : No

Device Count : 1

DRI Cotinine Calibrator Kit - 00884883001060 Catalog Number :

Device Class : 1

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : MKU

Prescription Use : No

Device Count : 1

DRI Cotinine Low Control - 00884883001077 Catalog Number :

Device Class : 1

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : MKU

Prescription Use : No

Device Count : 1

DRI Cotinine High Control - 00884883001084 Catalog Number :

Device Class : 1

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : MKU

Prescription Use : No

Device Count : 1

DRI Serum Tox Negative Calibrator - 00884883001091 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : No

Device Count : 1

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