DEVICE: IgG RID Plate Kit (B1761015)

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Device Identifier (DI) Information

IgG RID Plate Kit
1
101511
KENT LABORATORIES INC
B1761015
HIBCC
1
Radial immunodiffusion plate package for human human IgG with three standards
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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 G (IgG total) IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
CGM Method, Immunodiffusion, Immunoglobulins (G, A, M)
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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 4 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
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

[?]
3603988641
donald@kentlabs.com
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