FDA.reportPublic FDA data

Identify Health Drug Screen Test Cup

Primary DI
20850721007840
Brand
Identify Health Drug Screen Test Cup
Company
MEDICAL DISTRIBUTION GROUP INC
Model
ID-H9-1
Catalog number
ID-H9-1
Device description
Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MET500/ MTD300/OPI300/OXY100
Published
2019-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DJCThin Layer Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJCThin Layer Chromatography, MethamphetamineClinical 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
20850721007840PackageGS18In Commercial Distribution
10850721007843PrimaryGS10
00850721007846Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085072100784020850721007840
1085072100784310850721007843
00850721007846008507210078468507210078460850721007846

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064177324
Device count
25
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
false
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
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
00194346667574EquateWAL-MART STORES, INC.DJC2026-04-07
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDJC2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-05-28
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10722066005139Rapid ResponseBTNX IncDJC2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2020-05-29
10722066005108Rapid ResponseBTNX IncDJC2020-02-12
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDJC2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-07-05
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-05-23
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-02-13
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-04-06