DEVICE: ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE) (05055273216486)
Device Identifier (DI) Information
ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE)
LV10366
In Commercial Distribution
LV10366
RANDOX LABORATORIES LIMITED
LV10366
In Commercial Distribution
LV10366
RANDOX LABORATORIES LIMITED
Enzymes Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for ALT, AST, Alkaline Phosphatase (ALP), Total Amylase, Pancreatic Amylase, CK, CKMB, Gamma GT, LDH and Lipase assays.
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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30213 | Multiple clinical chemistry enzyme IVD, control |
A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JJY | Multi-Analyte Controls, All Kinds (Assayed) |
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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Storage Environment Temperature: between -24 and -18 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
513e3c0b-fd66-43e6-b785-42f068cd4919
December 08, 2022
2
July 15, 2020
December 08, 2022
2
July 15, 2020
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