DEVICE: Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit (05055845400183)
Device Identifier (DI) Information
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit
FHRWR1000
In Commercial Distribution
FHRWR1000
AXIS-SHIELD DIAGNOSTICS LIMITED
FHRWR1000
In Commercial Distribution
FHRWR1000
AXIS-SHIELD DIAGNOSTICS LIMITED
The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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53751 | Homocysteine IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of homocysteine in a clinical specimen.
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Active | false |
FDA Product Code
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K083222 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
5c558849-95e3-4081-83af-1415f01a596b
July 06, 2018
3
July 01, 2016
July 06, 2018
3
July 01, 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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441382422000
MDL-AXD-Product-Support@alere.com
MDL-AXD-Product-Support@alere.com