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 ID00850013035168
NIH Device Record Key20e9e4e9-256a-47ad-8010-d48a6b1c230d
Commercial Distribution Discontinuation2099-03-02
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdentify Diagnostics USA
Version Model NumberID-US9-ADULT-2
Catalog NumberID-US9-ADULT-2
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850013035168 [Unit of Use]
GS110850013035165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXMEnzyme Immunoassay, Benzodiazepine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-08
Device Publish Date2022-02-28

On-Brand Devices [Identify Diagnostics USA]

20850721007895Identify Diagnostics USA Drug Test Dip Card - AMP500/BAR300/BUP10/BZO300/COC150/MET500/MTD300/OP
20850721007888IDENTIFY DIAGNOSTICS USA DRUG SCREEN CUP AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET50
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
00850013035137Identify Diagnostics USA Drug Test Dip Card- THC (50) Cannabinoids 50 ng/ml
00850013035144(Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - BUP10, BZO300, COC150, MTD300, MOR30
00850013035151dentify Diagnostics USA 8 Panel Drug Test Cup CLIA Waived - 3.0mm Test Strip AMP500, BUP10, BZO
00850013035168Identify Diagnostics USA 9 Panel Drug Test Cup w/ Adulterations CLIA Waived MADE IN USA AMP500,
00850013035175IDENTIFY DIAGNOSTICS USA DRUG SCREEN TEST CUP AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/

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