DEVICE: ADVIA® Chemistry FRT Ferritin Reagents (00630414590189)
Device Identifier (DI) Information
ADVIA® Chemistry FRT Ferritin Reagents
10361938
In Commercial Distribution
4862277
Siemens Healthcare Diagnostics Inc.
10361938
In Commercial Distribution
4862277
Siemens Healthcare Diagnostics Inc.
Ferritin - ADVIA Chem. - RGT - 4x200 tests
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? |
---|---|---|---|---|
53718 | Ferritin IVD, kit, nephelometry/turbidimetry |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of ferritin in a clinical specimen, using a nephelometry/turbidimetry method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DBF | FERRITIN, ANTIGEN, ANTISERUM, CONTROL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K110736 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Do not freeze |
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
f0f5b844-9b22-4a79-9f51-a8b4b2584972
November 18, 2021
5
September 24, 2016
November 18, 2021
5
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 |
---|---|---|---|---|---|
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
[?]
+1(877)229-3711
CONTACT@SIEMENS-HEALTHINEERS.COM
CONTACT@SIEMENS-HEALTHINEERS.COM