Identify Health Drug Screen Test Cup ID-H6-1

GUDID 20850721007857

Identify Health Drug Screen Test Cup AMP500/BZO300/COC150/OPI300/OXY100/THC50

MEDICAL DISTRIBUTION GROUP INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID20850721007857
NIH Device Record Key3af2c1b6-fec0-41bb-946b-2a20eee2236e
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 Datefalse
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
GS100850721007853 [Unit of Use]
GS110850721007850 [Primary]
GS120850721007857 [Package]
Contains: 10850721007850
Package: case [8 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-05-24
Device Publish Date2019-02-27

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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