DEVICE: RenalytixAI Urine Collection Kit (00860009877917)
Device Identifier (DI) Information
RenalytixAI Urine Collection Kit
RENX3011003
In Commercial Distribution
Renalytix Ai, Inc.
RENX3011003
In Commercial Distribution
Renalytix Ai, Inc.
Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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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? |
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65196 | General specimen collection kit |
A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OIE | Urine Collection Kit (Excludes Hiv Testing) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
75f43196-36e1-4eb8-9cb5-1f045d969a82
April 10, 2024
4
May 06, 2022
April 10, 2024
4
May 06, 2022
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
[?]
800-203-2725
ClientServices@renalytix.com 3175121312
bhuff@renalytix.com 6469466690
aflynn@renalytix.com
ClientServices@renalytix.com 3175121312
bhuff@renalytix.com 6469466690
aflynn@renalytix.com