FDA.reportPublic FDA data

Identify Health Drug Screen Test Cup

Primary DI
10850013035011
Brand
Identify Health Drug Screen Test Cup
Company
MEDICAL DISTRIBUTION GROUP INC
Model
ID-H7-1
Catalog number
ID-H7-1
Device description
Identify Health, 7 Panel Drug Screen Test Cup, CLIA Waived(AMP500, BUP10, BZO300, COC150, OPI300, OXY100, THC50)Contents: Test Cups - 25, Package Insert - 1, Security Seals - 25, For In Vitro Diagnostics Use
Published
2019-09-26
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
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122809000Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech2013-06-17DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850013035011PrimaryGS10
00850013035007Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001303501110850013035011
00850013035007008500130350078500130350070850013035007

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064177324
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850013035431Identify Health Drug Screen Test CupID-H8-2-AZ5ID-H8-2-AZ52026-06-25
10850013035448Identify Health Drug Screen Test CupID-H8-2-AZ25ID-H8-2-AZ252026-06-25
10850013035400Identify®Diagnostics Drug Test DipID-AT14-DIP-1-AZ5ID-AT14-DIP-1-AZ52026-05-28
10850013035417Identify®Diagnostics Drug Test DipsID-AT14-DIP-1-AZ25ID-AT14-DIP-1-AZ252026-05-28
10850013035424Identify®Diagnostics Drug Test DipID-AT14-DIP-1-AZ1ID-AT14-DIP-1-AZ12026-05-28
10850013035530Identify®Diagnostics Drug Test CupsID-CP10-DIP-AZ1ID-CP10-DIP-AZ12026-05-28
10850013035547Identify®Diagnostics Drug Test DipID-CP6-DIP-AZ1ID-CP6-DIP-AZ12026-05-28
10850013035554Identify®Diagnostics Drug Test DipID-CP5-DIP-AZ1ID-CP5-DIP-AZ12026-05-28
10850013035561Identify HealthID-H10-DIP-1-AZ1ID-H10-DIP-1-AZ12026-05-28
10850013035677Identify®Diagnostics Drug Test CupsID-CP12-BUP-AZ1ID-CP12-BUP-AZ12026-05-28
10850013035684Identify®Diagnostics Drug Test CupsID-CP10-AZ1ID-CP10-AZ12026-05-28
10850013035691Identify®Diagnostics Drug Test DipID-CP6-AZ1ID-CP6-AZ12026-05-28
10850013035707Identify®Diagnostics Drug Test CupsID-CP5-AZ1ID-CP5-AZ12026-05-28
10850013035523Identify Diagnostics USAID-US14-ADULT-AZ1ID-US14-ADULT-AZ12026-05-21
10850013035578Identify Health Drug Screen Test CupID-H7-1-AZ1ID-H7-1-AZ12026-05-21
10850013035585Identify HealthID-H14-ADULT-1-AZ1ID-H14-ADULT-1-AZ12026-05-21
10850013035592Identify Health Drug Screen Test CupID-H6-1-AZ1ID-H6-1-AZ12026-05-21
10850013035608Identify HealthID-H12-2-AZ1ID-H12-2-AZ12026-05-21
10850013035622Identify HealthID-AT10-1-AZ1ID-AT10-1-AZ12026-05-21
10850013035639Identify HealthID-AT10-1-AZ25ID-AT10-1-AZ252026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841824104167ECOIIW.H.P.M. INC.DKZ2026-07-07
00841824104167ECOIIW.H.P.M. INC.JXM2026-07-07
00841824104167ECOIIW.H.P.M. INC.DIO2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
00841824104167ECOIIW.H.P.M. INC.LDJ2026-07-07
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03