Bicycle Health ID-BH9-ADULT-1-AZ25

GUDID 00850013035205

Bicycle Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (NI/CR) Approx. 3mm Strip 25 Tests/Box

MEDICAL DISTRIBUTION GROUP INC

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Primary Device ID00850013035205
NIH Device Record Key5d3dab67-35be-41dd-9481-df38d9827e43
Commercial Distribution Discontinuation2045-07-03
Commercial Distribution StatusIn Commercial Distribution
Brand NameBicycle Health
Version Model NumberID-BH9-ADULT-1-AZ25
Catalog NumberID-BH9-ADULT-1-AZ25
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850013035205 [Unit of Use]
GS110850013035202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-01
Device Publish Date2023-07-24

Devices Manufactured by MEDICAL DISTRIBUTION GROUP INC

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 2023-08-01Bicycle Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (NI/CR) Approx. 3mm 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, (
00850013035182 - Identify Health2023-03-16 Identify Health 14 Panel CLIA Waived Cup with 6 Adulterations- AMP500, BAR300, BUP10, BZO300, COC150, EDDP300, MDMA500, MET500,
00850013035175 - Identify Diagnostics USA2022-08-09 IDENTIFY DIAGNOSTICS USA DRUG SCREEN TEST CUP AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/MTD300/OPI300/OXY100/PCP2
00850013035168 - Identify Diagnostics USA2022-03-08 Identify Diagnostics USA 9 Panel Drug Test Cup w/ Adulterations CLIA Waived MADE IN USA AMP500, BAR300, BUP10, BZO300, COC150,
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