Identify Diagnostics USA ID-US9-ADULT-2

GUDID 00850013035168

Identify Diagnostics USA 9 Panel Drug Test Cup w/ Adulterations CLIA Waived MADE IN USA AMP500, BAR300, BUP10, BZO300, COC150, MET500, MTD300, MOP300, OXY100, (pH, SG, CR) 25 tests/box

MEDICAL DISTRIBUTION GROUP INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	00850013035168
NIH Device Record Key	20e9e4e9-256a-47ad-8010-d48a6b1c230d
Commercial Distribution Discontinuation	2099-03-02
Commercial Distribution Status	In Commercial Distribution
Brand Name	Identify Diagnostics USA
Version Model Number	ID-US9-ADULT-2
Catalog Number	ID-US9-ADULT-2
Company DUNS	064177324
Company Name	MEDICAL DISTRIBUTION GROUP INC
Device Count	25
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013035168 [Unit of Use]
GS1	10850013035165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K122809

FDA Product Code

JXM	Enzyme Immunoassay, Benzodiazepine

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-03-08
Device Publish Date	2022-02-28

On-Brand Devices [Identify Diagnostics USA]

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20850721007949	(Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - AMP500, BZO300, COC150, MOR/OPI300,
20850721007932	(Identify USA - Drug Test Cups) / 12 Panel CLIA Waived Cup - AMP500, BAR300, BUP10, BZO300, COC
00850013035137	Identify Diagnostics USA Drug Test Dip Card- THC (50) Cannabinoids 50 ng/ml
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00850013035151	dentify Diagnostics USA 8 Panel Drug Test Cup CLIA Waived - 3.0mm Test Strip AMP500, BUP10, BZO
00850013035168	Identify Diagnostics USA 9 Panel Drug Test Cup w/ Adulterations CLIA Waived MADE IN USA AMP500,
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