DEVICE: Origin Instant Drug Test (B778610073OD0)
Device Identifier (DI) Information
Origin Instant Drug Test
61007-3-OD
In Commercial Distribution
61007-3-OD
ORIGIN DIAGNOSTICS LLC
61007-3-OD
In Commercial Distribution
61007-3-OD
ORIGIN DIAGNOSTICS LLC
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC-pH,SG,OX
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid | A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LDJ | Enzyme Immunoassay, Cannabinoids |
DJG | Enzyme Immunoassay, Opiates |
DJR | Enzyme Immunoassay, Methadone |
LAF | Gas Chromatography, Methamphetamine |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
JXM | Enzyme Immunoassay, Benzodiazepine |
DIS | Enzyme Immunoassay, Barbiturate |
DKZ | Enzyme Immunoassay, Amphetamine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 39 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4c103ad7-0b11-41ff-8006-f95910326a6c
May 24, 2021
2
January 22, 2020
May 24, 2021
2
January 22, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-440-6695
orders@origin.net
orders@origin.net