DEVICE: Human Caeruloplasmin NL BINDARID™ Radial Immunodiffusion Kit (05051700010719)

Device Identifier (DI) Information

Human Caeruloplasmin NL BINDARID™ Radial Immunodiffusion Kit
RN045.3
In Commercial Distribution

THE BINDING SITE GROUP LIMITED
05051700010719
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
Ceruloplasmin IVD, kit, precipitation/immunodiffusion A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ceruloplasmin in a clinical specimen, using a precipitation/immunodiffusion method. Ceruloplasmin is a copper carrying protein which is a marker for Wilson’s disease.
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FDA Product Code

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Product Code Product Code Name
DDB Ceruloplasmin, Antigen, Antiserum, Control
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K913668 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

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Size Type Text
No Device Sizes
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Device Record Status

613df01a-def4-4de5-8403-22a1529842a4
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

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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

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