DEVICE: IgE CAL SET (05055273203912)

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Device Identifier (DI) Information

IgE CAL SET
IE2492
IE2492
RANDOX LABORATORIES LIMITED
05055273203912
GS1
1
This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems.
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Device Characteristics

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

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

GMDN Preferred Term Name GMDN Definition
Multiple allergen-specific/total immunoglobulin E (IgE) antibody 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 measurement of immunoglobulin E (IgE) antibodies to multiple specific protein allergens and/or total immunoglobulin E (IgE total) in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
DGC Ige, Antigen, Antiserum, Control
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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: After reconstitution, the material is stable for 4 weeks at +2°C to +8°C.
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+442894451070
technical.services@randox.com
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