DEVICE: Alpha2-macroglobulin (05415168006873)
Device Identifier (DI) Information
Alpha2-macroglobulin
09029524190
In Commercial Distribution
09029524190
Diagam
09029524190
In Commercial Distribution
09029524190
Diagam
In vitro diagnostic reagent for the quantitative determination of alpha2macroglobulin in samples of human origin (serum, heparinized plasma) by immunoturbidimetry on the cobas c systems.
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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53925 | Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of alpha-2-macroglobulin in a clinical specimen, using a nephelometry/turbidimetry method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control |
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 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
349a46f4-4ac9-46e0-84c8-1dba8ceaf106
December 15, 2021
1
December 07, 2021
December 15, 2021
1
December 07, 2021
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
[?]
No Customer Contact currently defined