FDA.reportPublic FDA data

CEDIA Methadone Metabolite Assay

Primary DI
00884883012530
Brand
CEDIA Methadone Metabolite Assay
Company
Microgenics Corporation
Model
10016421
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980746000CEDIA DAU EDDP ASSAYBoehringer Mannheim Corp.1998-05-26DJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883012530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883012530008848830125308848830125300884883012530

GMDN Terms#

Term, Definition table
TermDefinition
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 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 the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 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
00884883009080MAS Immunology Advanced Sample PackICA-S12026-05-27
00884883011373MAS Immunology Advanced Level 1ICA-1012026-05-27
00884883011380MAS Immunology Advanced Level 2ICA-2022026-05-27
00884883011397MAS Immunology Advanced Level 3ICA-3032026-05-27
00884883011427CRP (C-Reactive Protein)75-54422026-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJR2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDJR2021-06-24
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2019-09-28
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
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2018-03-30