FDA.reportPublic FDA data

Identify® Diagnostics Drug Test Cups

Primary DI
10850721007959
Brand
Identify® Diagnostics Drug Test Cups
Company
MEDICAL DISTRIBUTION GROUP INC
Model
ID-CP12-BUP-AZ10
Catalog number
ID-CP12-BUP-AZ10
Device description
Identify®Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/MOP/OXY/PCP/THC with Adulteration strip (S.G./CRE/pH)Identify® Diagnostics Drug Test Cups12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
Published
2019-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131811000UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSUcp Biosciences, Inc.2013-07-19DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850721007956PackageGS120In Commercial Distribution
10850721007959PrimaryGS10
00850721007952Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085072100795620850721007956
1085072100795910850721007959
00850721007952008507210079528507210079520850721007952

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064177324
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10850013035646Identify HealthID-AT10-1-AZ50ID-AT10-1-AZ502026-05-21
10850013035653Identify HealthID-AT10-1-AZ100ID-AT10-1-AZ1002026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
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 CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03