FDA.reportPublic FDA data

DRI Methadone Assay

Primary DI
00884883003392
Brand
DRI Methadone Assay
Company
Microgenics Corporation
Model
0596
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DJREnzyme Immunoassay, Methadone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJREnzyme Immunoassay, MethadoneClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883003392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883003392008848830033928848830033920884883003392

GMDN Terms#

Term, Definition table
TermDefinition
Methadone 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 methadone in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122153799
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884883006751DRI Ecstasy Plus Assay100246312018-09-27
00884883001558CEDIA Heroin Metabolite (6-AM) Assay1001072016-09-26
00884883004245CEDIA Heroin Metabolite (6-AM) Assay1001082016-09-22
00884883004306CEDIA Heroin Metabolite (6-AM) Assay1001862016-09-21
00884883011366CEDIA Heroin Metabolite (6-AM) Assay100152132016-09-21
00884883009301MAS Omni•IMMUNE Max, Level 1OIMM-1012025-08-12
00884883009318MAS Omni•IMMUNE Max, Level 2OIMM-2022025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3OIMM-3032025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackOIMM-SP2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1OPROM-1012025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2OPROM-2022025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3OPROM-3032025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackOPROM-SP2025-08-12
00884883009257MAS OmniCORE Max, Level 1OCRM-1012025-06-27
00884883009264MAS OmniCORE Max, Level 2OCRM-2022025-06-27
00884883009271MAS OmniCORE Max, Level 3OCRM-3032025-06-27
00884883009288MAS OmniCORE Max, Sample PackOCRM-SP2025-06-27
00884883009219MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 1OCRL-1012025-01-31
00884883009226MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 2OCRL-2022025-01-31
00884883009233MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 3OCRL-3032025-01-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDJR2019-03-11
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2019-02-12
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDJR2018-10-29
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDJR2018-04-20
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10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-12
10694644400677INCUPAMERICAN BIO MEDICA CORPORATIONDJR2017-10-10
10694644500278RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500285RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500292RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500308RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500315RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500322RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-10-06
10694644500254RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-08-02
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2017-06-29
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2017-06-08
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10694644400653INCUPAMERICAN BIO MEDICA CORPORATIONDJR2017-03-21