Identify R Diagnostics Drug Test Cups ID-CP12-BUP

GUDID 20850721007390

Identify R Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY

MEDICAL DISTRIBUTION GROUP INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID20850721007390
NIH Device Record Keya7767165-bc97-4d47-9192-f05d55f6de90
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdentify R Diagnostics Drug Test Cups
Version Model NumberID-CP12-BUP
Catalog NumberID-CP12-BUP
Company DUNS064177324
Company NameMEDICAL DISTRIBUTION GROUP INC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850721007396 [Unit of Use]
GS110850721007393 [Primary]
GS120850721007390 [Package]
Contains: 10850721007393
Package: case [8 Units]
In Commercial Distribution

FDA Product Code

LCMEnzyme Immunoassay, Phencyclidine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-05-24
Device Publish Date2017-02-11

Devices Manufactured by MEDICAL DISTRIBUTION GROUP INC

00850013035229 - Identify® Diagnostics Drug Test Cups 2025-01-03 Identify® Diagnostics Drug Test Cups 9-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/OPI/OXY/PCP
00850013036004 - Identify Health Drug Screen Test Cup2024-11-28 Identify Health 6 Panel Drug Screen Test Cup - CLIA Waived AMP500, COC150, MET500, OPI300, PCP25 THC50 3mm Strip - 25 Pack Box
00850013035519 - Identify Health Drug Screen Test Cup2024-08-30 Identify Health Drug Screen Test Cup AMP500/COC150/OPI300/OXY100/PCP25,THC50
00850013035502 - Identify Health 2023-12-15 Identify Health Drug Test Dip Card - AMP500/BAR300/BUP10/BZO300/COC150/MET500/MTD300/OPI300/OXY100/THC50
00850013035212 - Identify® Diagnostics Drug Test Cups 2023-11-23 12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
00850013035304 - Identify Health 2023-08-11 Identify Health 4 Panel Drug Test Dip- CLIA Waived AMP500, COC150, MOP300, PCP25 Approx. 3.0mm strip 25 Tests/Box
00850013035205 - Bicycle Health 2023-08-01 Bicycle Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (N
00850013035199 - Identify Health2023-05-19 Identify Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.