DEVICE: GenaCheck™ Fentanyl Urine Home-Use Test Cassette (00860008954800)

Device Identifier (DI) Information

GenaCheck™ Fentanyl Urine Home-Use Test Cassette
RA9-E02525
In Commercial Distribution
RA9-E02501
Genabio Diagnostics Inc.
00860008954800
GS1

1
118586095 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
Yes
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?
55461 Multiple drugs of abuse IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NGL Test, Opiates, Over The Counter
DJG Enzyme Immunoassay, Opiates
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K233417 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

b7904151-c7f5-43b8-b4af-484b8a7d81f0
August 13, 2024
2
June 14, 2024
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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
10860008954807 108 00860008954800 In Commercial Distribution Carton
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Secondary DI

[?]
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

[?]
1-800-614-3365
info@genabio.com
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