DEVICE: OEM 81-13 Drug Test (10817038022129)

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Device Record History
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Device Identifier (DI) Information
OEM 81-13 Drug Test
U-DOA-134
In Commercial Distribution
U-DOA-134
UCP BIOSCIENCES, INC.
10817038022129
GS1
April 06, 2033
25
163610020 *Terms of Use
OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
Yes
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?
55489 Amphetamine/methamphetamine group 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 belonging to the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] 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.
Active false
30520 Cocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites 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.
Active false
30519 Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DKZ Enzyme Immunoassay, Amphetamine
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJ Enzyme Immunoassay, Cannabinoids
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K131811 000
No 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
e9b545c4-ef04-420c-9fec-9331dc428bf7
April 17, 2023
1
April 07, 2023
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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
20817038022126 50 10817038022129 2023-04-06 Not in Commercial Distribution case
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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: 00817038022122 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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