DEVICE: Origin Instant Oral Drug Test (B77880600ODEI0)
Device Identifier (DI) Information
Origin Instant Oral Drug Test
80600-OD-EI
In Commercial Distribution
80600-OD-EI
ORIGIN DIAGNOSTICS LLC
80600-OD-EI
In Commercial Distribution
80600-OD-EI
ORIGIN DIAGNOSTICS LLC
Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI-THC
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46994 | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
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 [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PVJ | Test, Cannabinoid, Employment And Insurance Testing, Exempt |
PVH | Test, Opiates, Employment And Insurance Testing, Exempt |
PVD | Test, Methamphetamine, Employment And Insurance Testing, Exempt |
PVA | Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt |
PUZ | Test, Benzodiazepine, Employment And Insurance Testing, Exempt |
PUX | Test, Amphetamine, Employment And Insurance Testing, Exempt |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cf0bf9ba-c645-42c6-8684-96b0f649c1c9
June 10, 2022
3
January 24, 2020
June 10, 2022
3
January 24, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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