DEVICE: Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BNII Analyser (05051700007764)

Device Identifier (DI) Information

Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BNII Analyser
NK008.T
In Commercial Distribution

THE BINDING SITE GROUP LIMITED
05051700007764
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
Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen, using a nephelometry/turbidimetry method.
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FDA Product Code

[?]
Product Code Product Code Name
CFN Method, Nephelometric, Immunoglobulins (G, A, M)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K012295 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

aeb36e24-0fe9-40e9-a775-7f1894ae5901
September 14, 2018
4
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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