FDA.reportPublic FDA data

Identify®Diagnostics Drug Test Cups

Primary DI
00850013035076
Brand
Identify®Diagnostics Drug Test Cups
Company
MEDICAL DISTRIBUTION GROUP INC
Model
ID-CP10-AZ15
Catalog number
ID-CP10-AZ15
Device description
Identify® Diagnostics Drug Test Cups 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
Published
2025-09-11
Public version status
New
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
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

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
10850013036148PrimaryGS10
00850013035076Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001303614810850013036148
00850013035076008500130350768500130350760850013035076

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.

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
15
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
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
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLCM2019-02-13
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-02-13
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2017-10-12
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2017-06-29