DEVICE: Origin Instant Oral Drug Test (B77880510ODEI0)

Device Identifier (DI) Information

Origin Instant Oral Drug Test
80510-OD-EI
In Commercial Distribution
80510-OD-EI
ORIGIN DIAGNOSTICS LLC
B77880510ODEI0
HIBCC

1
036225773 *Terms of Use
Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI
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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 one or 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.
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FDA Product Code

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Product Code Product Code Name
PUX Test, Amphetamine, Employment And Insurance Testing, Exempt
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt
PVH Test, Opiates, Employment And Insurance Testing, Exempt
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

86e303bd-ea41-48fc-9245-376e4101f607
January 27, 2021
1
January 19, 2021
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-440-6695
orders@origin.net
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