DEVICE: OC-Auto (00855574005100)
Device Identifier (DI) Information
OC-Auto
MV5F00
In Commercial Distribution
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
MV5F00
In Commercial Distribution
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OC-Auto SENSOR Diana FIT Analyzer
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
56703 | Faecal occult blood immunoassay analyser IVD |
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of faecal occult blood, using an immunological method to detect or measure haemoglobin in a clinical stool (faeces) specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OOX | Automated Occult Blood Analyzer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K092330 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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
314718f0-9793-49a8-9d2c-40b51d5385de
September 16, 2022
4
September 23, 2016
September 16, 2022
4
September 23, 2016
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
[?]
No Customer Contact currently defined