FDA.reportPublic FDA data

DRI Multi-Drug Urine Calibrator 4

Primary DI
00884883011502
Brand
DRI Multi-Drug Urine Calibrator 4
Company
Microgenics Corporation
Model
1597
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
DKBCalibrators, Drug Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983159000DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSDiagnostic Reagents, Inc.1998-11-05DKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883011502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883011502008848830115028848830115020884883011502

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122153799
Device count
1
Premarket exempt
true
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
00840937114636ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114643ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114650ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114667ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00613647025291FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
20613647025295FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
00840937112083ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112090ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112106ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112113ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00811727016850Pointe Universal Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017550Pointe Multi-Analyte Set C Urine DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017567Pointe Multi-Analyte Set C Urine DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017574Pointe Multi-Analyte Set C Urine DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017581Pointe Multi-Analyte Set C Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017611Pointe Multi-Analyte Set D Urine DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017628Pointe Multi-Analyte Set D Urine DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017635Pointe Multi-Analyte Set D Urine DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017642Pointe Multi-Analyte Set D Urine DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017659Pointe Multi-Analyte Set D Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017680Pointe Multi-Analyte E DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017697Pointe Multi-Analyte E DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017703Pointe Multi-Analyte E DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017710Pointe Multi-Analyte E DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017727Pointe Multi-Analyte E DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00380740179342AlinityABBOTT LABORATORIESDKB2020-05-11
00380740179359AlinityABBOTT LABORATORIESDKB2020-05-11
00380740179366AlinityABBOTT LABORATORIESDKB2020-05-11
00840937111895ImmunalysisIMMUNALYSIS CORPDKB2020-03-31
00840937111918ImmunalysisIMMUNALYSIS CORPDKB2020-03-31