FDA.report

CEDIA Phenobarbital II Assay

Primary DI
00884883001237
Brand
CEDIA Phenobarbital II Assay
Company
Microgenics Corporation
Model
100003
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DLZEnzyme Immunoassay, Phenobarbital
LAFGas Chromatography, Methamphetamine

Product Code Classifications

CodeDeviceSpecialtyClass
DLZEnzyme Immunoassay, PhenobarbitalClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2

Premarket Submissions

SubmissionSupplement
K904413000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K904413000CEDIA(TM) PHENOBARBITAL ASSAYMicrogenics Corp.1990-11-05LAF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884883001237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883001237008848830012378848830012370884883001237

GMDN Terms

TermDefinition
Phenobarbital IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of phenobarbital in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods

Method

Regulatory Flags

DUNS number
122153799
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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