FDA.reportPublic FDA data

McKesson

Primary DI
20612479258444
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
MCK03-4490
Device description
Test Kit, Drug Screen Cup, 14-Panel, Waived
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479258444PackageGS125In Commercial Distribution
10612479258430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247925844420612479258444
1061247925843010612479258430

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035523Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850013035585Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850013035608Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850076289062Hysen Drug Test CupsHYSEN INC.LFG2026-03-18
10850076289000Hysen Drug Test CupsHYSEN INC.LFG2025-08-04
10850076289017Hysen Drug Test CardsHYSEN INC.LFG2025-08-04
10858886006848Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2025-01-17
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.LFG2024-02-09
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.LFG2023-11-30
10858886006824Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLFG2023-10-20
10817038022174Number OneUCP BIOSCIENCES, INC.LFG2023-06-16
10850013035189Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2023-03-08
10858886006770Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2023-02-14
10796918002447Multi-Drug of Abuse Urine Cup TestALFA SCIENTIFIC DESIGNS, INC.LFG2022-11-07
10850013035172Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLFG2022-08-01
10858886006701Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-07-14
10858886006688Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-06-14
10858886006565Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLFG2022-04-28
10858886006572Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-04-28
10858886006596Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-04-28
20869419000230Express ResultsTM Quest DiagnosticsLFG2022-03-28
20869419000247Express ResultsTM Quest DiagnosticsLFG2022-03-28
30869419000237Express ResultsTM Quest DiagnosticsLFG2022-03-28
10817815020683CRL Stat Dip CardW.H.P.M. INC.LFG2021-08-25
10796918002423INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300ALFA SCIENTIFIC DESIGNS, INC.LFG2021-07-29
10796918002201INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300ALFA SCIENTIFIC DESIGNS, INC.LFG2021-04-21
10796918002195INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR30ALFA SCIENTIFIC DESIGNS, INC.LFG2020-09-14
10817405021311iScreen™Instant Technologies, Inc.LFG2020-08-21
10817405021328iScreen™Instant Technologies, Inc.LFG2020-08-21
10817038022037UCP Compact Drug Test CassetteUCP BIOSCIENCES, INC.LFG2020-06-24