FDA.reportPublic FDA data

DRI Methadone Assay

Primary DI
00884883002913
Brand
DRI Methadone Assay
Company
Microgenics Corporation
Model
0597
Published
2016-09-06
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
false

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
00884883002913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883002913008848830029138848830029130884883002913

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884883009240MAS Omni-Core II Liquid Assayed Integrated Chemistry Control Sample PackOCRL-SP2025-01-31
00884883008830MAS Diabetes Max-SP (Sample-Pack)B400006882024-05-21
00884883008823MAS Diabetes Max, Multi-packB400006872024-05-20
00884883006027Acrometrix BB NAT HBV Positive Control9636032022-10-07
00884883007376MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays10027480-U2021-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810173656020HealgenHealgen Scientific Limited Liability CompanyDJR2026-03-11
00810173655507Healgen Healgen Scientific Limited Liability CompanyDJR2026-02-04
10810173655580HealgenHealgen Scientific Limited Liability CompanyDJR2026-02-04
00810173654944HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-31
00810173654951HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-31
00810173655033HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-31
10810173655634HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-30
10810173654750Healgen Healgen Scientific Limited Liability CompanyDJR2026-01-08
10810173653999HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
10810173654569HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
10810173654613HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
10810173654668HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
00850013035991Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJR2025-12-15
00850013035731Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
00850013035762Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
00850013035779Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
00850013035847Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
00850013035861Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
00850013035885Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-12-04
00850721007297Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2025-09-11
00850013035229Identify® Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2024-12-26
10815845024275SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJR2024-12-17
00812203030711GenericCHEMTRON BIOTECH INCDJR2024-04-08
10810124273078SureStepTM Urine Test Drug Screen Strip, Methadone (MTD 300)ALERE SAN DIEGO, INC.DJR2023-12-15
00850013035212Identify® Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCDJR2023-11-15
00812203030612DrugSmart Cup 10CHEMTRON BIOTECH INCDJR2023-03-23
30817405022299iScreen™Instant Technologies, Inc.DJR2023-02-07
10817405023032iCup™Instant Technologies, Inc.DJR2023-02-06
D112POLI712HP1Strauss DiamondDiamond Strauss Instruments IncDJR2022-10-14
00695684410117SAFECUP III MULTIDRUG 11GERMAINE LABORATORIES, INCDJR2022-08-17