Identify Health Drug Screen Test Cup ID-H6-1

GUDID 00850013035519

Identify Health Drug Screen Test Cup AMP500/COC150/OPI300/OXY100/PCP25,THC50

MEDICAL DISTRIBUTION GROUP INC

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00850013035519
NIH Device Record Keya9463480-e1cf-4923-b03d-6efcf9cda956
Commercial Distribution Discontinuation2045-11-01
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdentify Health Drug Screen Test Cup
Version Model NumberID-H6-1
Catalog NumberID-H6-1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850013035519 [Unit of Use]
GS110850013035516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-30
Device Publish Date2024-08-22

On-Brand Devices [Identify Health Drug Screen Test Cup]

10850013035011Identify Health CLIA Waived 7 Panel Drug Test Cup AMP500/BUP10/BZO300/COC150/OPI300/OXY100/THC50
20850721007857Identify Health Drug Screen Test Cup AMP500/BZO300/COC150/OPI300/OXY100/THC50
20850721007840Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MET500/ MTD300/OPI300/OXY
20850721007833Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/ MET500/MTD300/OP
00850013035519Identify Health Drug Screen Test Cup AMP500/COC150/OPI300/OXY100/PCP25,THC50

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