DEVICE: Hevylite IgA Lambda Kit for Siemens BNII (05051700016926)

Device Identifier (DI) Information

Hevylite IgA Lambda Kit for Siemens BNII
NK624.T.A
In Commercial Distribution

THE BINDING SITE GROUP LIMITED
05051700016926
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 immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin A (IgA total) 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)
OPY Igal Heavy & Light Chain Combined
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140105 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

e26f5db3-28d1-4cab-b09c-6e8135a5409a
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

[?]
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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