DEVICE: Human Albumin NL BINDARID™ Radial Immunodiffusion Kit (05051700010689)

Device Identifier (DI) Information

Human Albumin NL BINDARID™ Radial Immunodiffusion Kit
RN032.3
In Commercial Distribution

THE BINDING SITE GROUP LIMITED
05051700010689
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
Albumin IVD, antibody One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
DCF Albumin, Antigen, Antiserum, Control
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K914391 000
No CLOSE

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

4b1845eb-90d8-4a3b-b248-9cf1b9fde7a3
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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