DEVICE: Human CH50 Calibrator set for use on SPAPLUS (05051700015615)

Device Identifier (DI) Information

Human CH50 Calibrator set for use on SPAPLUS
NC095.S
In Commercial Distribution

THE BINDING SITE GROUP LIMITED
05051700015615
GS1

1
347045614 *Terms of Use
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
Total complement activity (CH50) 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 complement activity (CH50 ) in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
JIX Calibrator, Multi-Analyte Mixture
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K113349 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a9bd31ea-5db0-4706-b8aa-b1313c6b3bf4
July 06, 2018
3
September 24, 2016
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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
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Secondary DI

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

[?]
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

[?]
+4401214569500
info@bindingsite.co.uk
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