McKesson

Primary DI
40612479269864
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-DFY-A102C
Device description
TEST KIT, FENTANYL URINE RAPID (25/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
40612479269864PackageGS140In Commercial Distribution
20612479269853PrimaryGS10
10612479271255Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247926986440612479269864
2061247926985320612479269853
1061247927125510612479271255

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
25
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
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
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500460OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11