FDA.reportPublic FDA data

Identify®Diagnostics Drug Test Cups

Primary DI
20850721007734
Brand
Identify®Diagnostics Drug Test Cups
Company
MEDICAL DISTRIBUTION GROUP INC
Model
ID-CP12-BUP-ADULT-AZ5
Catalog number
ID-CP12-BUP-ADULT-AZ5
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)
Published
2018-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130463000UCP HOME DRUG SCREENING TEST; CARDS, CUPSUcp Biosciences, Inc.2013-05-15DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850721007734PackageGS140In Commercial Distribution
10850721007737PrimaryGS10
00850721007730Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085072100773420850721007734
1085072100773710850721007737
00850721007730008507210077308507210077300850721007730

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 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. It is not intended to be used for self-testing.

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
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00841824104167ECOIIW.H.P.M. INC.LDJ2026-07-07
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10722066008369Rapid ResponseBTNX IncLDJ2024-02-26
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncLDJ2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18