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 Mixture (DKB) (5) Colorimetry, Acetaminophen (LDP) (2) Colorimetry, Salicylate (DKJ) (2) U.V. Spectrometry, Tricyclic Antidepressant Drugs (LFH) (1)

Premarket Exempt

No Yes

Clear

DRI Serum Tox Calibrator 1 - 00884883001107 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : No

Device Count : 1

DRI Serum Tox Calibrator 2 - 00884883001114 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : No

Device Count : 1

DRI Serum Tox Calibrator 3 - 00884883001121 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : No

Device Count : 1

DRI Serum Tox Calibrator 4 - 00884883001138 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : No

Device Count : 1

DRI Salicylate Serum Tox Assay - 00884883001145 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DKJ

Prescription Use : No

Device Count : 1

DRI Salicylate Calibrator Kit - 00884883001152 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : DKJ

Prescription Use : No

Device Count : 1

DRI Acetaminophen Serum Tox Assay - 00884883001169 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : LDP

Prescription Use : No

Device Count : 1

DRI Acetaminophen Serum Tox Calibrators - 00884883001176 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : LDP

Prescription Use : No

Device Count : 1

DRI Tricyclics Serum Tox Assay - 00884883001183 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : No

Product Code : LFH

Prescription Use : No

Device Count : 1

DRI Negative Urine Calibrator - 00884883001190 Catalog Number :

Device Class : 2

Duns Number: 122153799

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : No

Device Count : 1

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