DEVICE: Human C4 Kit for use on SPAPLUS (05051700015585)

Device Identifier (DI) Information

Human C4 Kit for use on SPAPLUS
NK025.S
In Commercial Distribution

THE BINDING SITE GROUP LIMITED
05051700015585
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
Complement components C4/C4c IVD, kit, nephelometry/turbidimetry A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade components C4 and/or C4c in a clinical specimen, using a nephelometry/turbidimetry method.
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FDA Product Code

[?]
Product Code Product Code Name
DBI Complement C4, Antigen, Antiserum, Control
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K100455 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

8d70dcdd-d48a-457e-99e3-fd5bea4e01d2
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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