DEVICE: EDDP CONTROL 2 (05055273207927)
Device Identifier (DI) Information
EDDP CONTROL 2
DA3124
In Commercial Distribution
DA3124
RANDOX LABORATORIES LIMITED
DA3124
In Commercial Distribution
DA3124
RANDOX LABORATORIES LIMITED
The Randox EDDP Control - Level 2 is intended for use in the Quality Control of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. The EDDP Control - Level 2 contains the specific drug EDDP.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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43802 | 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 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 the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DIF | Drug Mixture Control Materials |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K092258 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: The EDDP Quality Control materials are stable for 28 days at +2°C to +8ºC. |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a00a4e5b-a643-4c5e-9c01-b8c0098a172a
December 21, 2020
3
September 24, 2016
December 21, 2020
3
September 24, 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
[?]
+442894451070
technical.services@randox.com
technical.services@randox.com