DEVICE: TIBC Calibrator Set (00812137012173)
Device Identifier (DI) Information
TIBC Calibrator Set
2 x 2mL
In Commercial Distribution
502-157
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
2 x 2mL
In Commercial Distribution
502-157
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. Using the Direct TIBC reagents, measurement of the total iron-binding capacity of serum occurs in a fully automated manner, without the need for any off-line separation. Since the entire reaction process is monitored by the chemistry analyzer, it is necessary to calibrate the assay with serum-based calibrators which are carried through the same reaction process as the patient specimens.
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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53906 | Total iron binding capacity (TIBC) IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total iron binding capacity (TIBC) of a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JIT | Calibrator, Secondary |
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
94238155-0df7-43a6-ae95-91323d7f2942
March 29, 2018
2
October 13, 2016
March 29, 2018
2
October 13, 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:
00812137012463
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8004533328
quaity@cdsolinc.com
quaity@cdsolinc.com