FDA.reportPublic FDA data

SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 500)

Primary DI
00810124273040
Brand
SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 500)
Company
Alere San Diego, Inc.
Model
DME-U101-a-Sgl
Published
2023-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LAFGas Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAFGas Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810124273040PrimaryGS10
10810124273047Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810124273040008101242730408101242730400810124273040
1081012427304710810124273047

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
194854949
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810124272975CERTUM One Step Multi-Line Drug Screen EZ SplitDBO-167-022-a45651613262024-10-10
00810124272982SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 300)DAM-A101-a-Sgl2023-12-15
00810124272999SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 1000)DAM-101-a-Sgl2023-12-15
00810124273002SureStepTM Urine Test Drug Screen Strip, Barbiturates (BAR 300)DBA-101-a-Sgl2023-12-15
00810124273019SureStepTM Urine Test Drug Screen Strip, Buprenorphine (BUP10)DBU-101-a-Sgl2023-12-15
00810124273026SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)DBZ-101-a-Sgl2023-12-15
00810124273033SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 150)DCO-U101-a-Sgl2023-12-15
00810124273057SureStepTM Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500DMD-101-a-Sgl2023-12-15
00810124273064SureStepTM Urine Test Drug Screen Strip, Opiate (MOP 300)DMO-101-a-Sgl2023-12-15
00810124273071SureStepTM Urine Test Drug Screen Strip, Methadone (MTD 300)DMT-101-a-Sgl2023-12-15
00810124273088SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)DTC-101-a-Sgl2023-12-15
00810124273095SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50)DTH-101-a-Sgl2023-12-15
00810124273149SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-157-01245653390192024-09-17
00810124273156SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-167-52145653490192024-09-17
00810124273163SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-1107-02145653590192024-09-17
00810124273170SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-1107-01145653690192024-09-17
00810124273200SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 300)DCO-101-a-Sgl2023-12-15
00810124273217SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000)DME-101-a-Sgl2023-12-15
00810124273224SureStepTM Urine Test Drug Screen Strip, Opiate (OPI 2000)DMO-101-a-Sgl2023-12-15
00810124273231SureStepTM Urine Test Drug Screen Strip, Oxycodone (OXY 100)DOX-101-a-Sgl2023-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B298307220DrugCheck Express Diagnostic Int'l, Inc.LAF2026-02-19
10841824104737EZ CLICKW.H.P.M. INC.LAF2024-07-25
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.LAF2024-02-09
16936983144664DiscoverHangzhou AllTest Biotech Co., Ltd.LAF2023-11-30
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.LAF2023-11-30
B298305250DrugCheck Express Diagnostic Int'l, Inc.LAF2023-11-30
10833143000067iCup™Instant Technologies, Inc.LAF2023-09-12
10817763022609First SignW.H.P.M. INC.LAF2022-11-17
20869419000209Express ResultsTM Quest DiagnosticsLAF2022-03-28
10841824104843NAW.H.P.M. INC.LAF2021-10-12
10841824104812ECO II Cup ®W.H.P.M. INC.LAF2021-09-10
10817815020683CRL Stat Dip CardW.H.P.M. INC.LAF2021-08-25
10841824104805NAW.H.P.M. INC.LAF2021-08-25
10841824104782ECO II Cup ®W.H.P.M. INC.LAF2021-07-08
B2983057210DrugCheckExpress Diagnostic Int'l, Inc.LAF2021-06-18
10817405021304iScreen™Instant Technologies, Inc.LAF2020-08-21
10817405021311iScreen™Instant Technologies, Inc.LAF2020-08-21
10817405021328iScreen™Instant Technologies, Inc.LAF2020-08-21
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10858886006480NOBLE NOBLE MEDICAL INCLAF2020-04-21
B2983044510DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050110DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050410DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050810DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983055410DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983056010DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983058010DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983060010DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983069510DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23