FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040186746
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703928
Catalog number
5703928
Device description
14 panel urine drug screen, AMP1000, BAR300, BUP10, BZO300, COC300, EDDP300, mAMP/MET1000, MDMA500, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50
Published
2024-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTEST, AMPHETAMINE, OVER THE COUNTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040186746PrimaryGS10
00304040186749Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404018674610304040186746
00304040186749003040401867493040401867490304040186749

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA 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 [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
012430880
Device count
25
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500460OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11