DEVICE: IgE CAL SET (05055273203912)
Device Identifier (DI) Information
IgE CAL SET
IE2492
In Commercial Distribution
IE2492
RANDOX LABORATORIES LIMITED
IE2492
In Commercial Distribution
IE2492
RANDOX LABORATORIES LIMITED
This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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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? |
---|---|---|---|---|
43794 | 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 detection of immunoglobulin E (IgE) antibodies to one or multiple allergens and total immunoglobulin E (IgE total) antibodies in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DGC | Ige, Antigen, Antiserum, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K010855 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
647d1d8a-f790-4e63-9c40-04fd17effcd4
June 10, 2022
4
September 16, 2016
June 10, 2022
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 |
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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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+442894451070
technical.services@randox.com
technical.services@randox.com