FDA.reportPublic FDA data

McKesson

Primary DI
40612479269840
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233417000AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd.2023-10-26NGL

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
10722066015053Rapid ResponseBTNX IncNGL2026-05-15
10722066015084Rapid ResponseBTNX IncNGL2026-05-15
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983131657Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983131664Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983131671Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983131695Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983144770Discover Multi-Drug 9 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983148846Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine) Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983169599Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983169865Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983169872Discover Multi-Drug 8 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983170007Alltest Multi-Drug 12 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983170014Alltest Multi-Drug 13 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983170021Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983170038Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983171998Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983172025Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-15
16936983172414Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-14
16936983172421Alltest Multi-Drug 12 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-14
16936983179642Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NGL2026-04-14
16936983179963Multi-Drug 12 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-14