DEVICE: Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges (04987270235089)

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Device Identifier (DI) Information

Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges
235089

FUJIREBIO INC.
04987270235089
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy Vitamin D in a clinical specimen, using an enzyme immunoassay (EIA) method.
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FDA Product Code

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Product Code Product Code Name
MRG System, Test, Vitamin D
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests
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Device Status

In Commercial Distribution
September 16, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
610-240-3800
customersupport@fdi.com
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