FDA.reportPublic FDA data

McKesson

Primary DI
20612479269839
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-DFY-A102H
Device description
TEST KIT, FENTANYL URINE RAPID (5/kt)
Published
2024-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGLTest, Opiates, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479269840PackageGS164In Commercial Distribution
20612479269839PrimaryGS10
10612479269825Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247926984040612479269840
2061247926983920612479269839
1061247926982510612479269825

GMDN Terms#

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

Regulatory Flags#

DUNS number
023904428
Device count
5
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479288496McKesson16-SN1C2905ST2026-10-08
20612479288526McKesson16-SN05C2905ST2026-10-08
20612479288557McKesson16-SN1C2805ST2026-10-08
20612479288588McKesson16-SN1C2558ST2026-10-08
10612479285993McKessonEXT-STND-070-0652026-10-06
10612479286013McKessonEXT-SM-030-0802026-10-06
10612479235592McKesson16-18502020-06-10
10612479235608McKesson16-18522020-06-10
10612479258317McKesson16-18602020-06-25
10612479258348McKesson16-18622020-06-25
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NGL2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NGL2026-10-27
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGL2026-10-13
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
10722066005511Rapid ResponseBTNX IncNGL2026-10-09
10722066018979Rapid ResponseBTNX IncNGL2026-10-08
10722066019013Rapid ResponseBTNX IncNGL2026-10-08
10722066019020Rapid ResponseBTNX IncNGL2026-10-08
10722066019037Rapid ResponseBTNX IncNGL2026-10-08
10722066019044Rapid ResponseBTNX IncNGL2026-10-08
10722066018955Rapid ResponseBTNX IncNGL2026-10-06
10722066018696Rapid ResponseBTNX IncNGL2026-09-18
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-08-14
06936983113953Alltest MOP300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113977Alltest MOP2000 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113984Alltest OXY100 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114103Alltest MOP300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114127Alltest MOP2000 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114134Alltest OXY100 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114202Alltest BUP10 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114226Alltest OXY100 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114240Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114301Alltest MOP2000 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114325Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114400Alltest MOP2000 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21