DEVICE: Lumipulse G 25-OH Vitamin D Calibrators (04987270234020)
Device Identifier (DI) Information
Lumipulse G 25-OH Vitamin D Calibrators
234020
Not in Commercial Distribution
FUJIREBIO INC.
234020
Not in Commercial Distribution
FUJIREBIO INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
54474 | Multiple form 25-hydroxy Vitamin D IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIT | Calibrator, Secondary |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: right side up with care; no vibration |
Storage Environment Temperature: between 2 and 10 Degrees Celsius |
Handling Environment Temperature: between 2 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Size Type = Units per Kit; Units = 6; Units of measure = 1.5mL |
Device Record Status
ee32e780-cff7-4b56-99be-8a58875d9ff4
January 13, 2023
4
September 16, 2016
January 13, 2023
4
September 16, 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
[?]
610-240-3800
customersupport@fdi.com
customersupport@fdi.com