DEVICE: 125I TSH Receptor Antibody Kit (TRAb PEG) (With Calibrators) (B126KR61650)

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Device Identifier (DI) Information

125I TSH Receptor Antibody Kit (TRAb PEG) (With Calibrators)
KR6165
KR6165
KRONUS, INC.
B126KR61650
HIBCC
1
A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Thyroid stimulating hormone receptor immunoglobulin (TSI) IVD, kit, radioimmunoassay A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone receptor immunoglobulins (TSI) or auto-antibodies directed to the thyroid stimulating hormone receptor (may also be referred to as long acting thyroid stimulators), in a clinical specimen using a radioimmunoassay method.
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FDA Product Code

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Product Code Product Code Name
JZO System, Test, Thyroid Autoantibody
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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800-457-6687
kronus@kronus.com
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