DEVICE: TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KIT (B126KR70600)

Device Identifier (DI) Information

TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KIT
KR7060
In Commercial Distribution
KR7060
KRONUS, INC.
B126KR70600
HIBCC

1
181070814 *Terms of Use
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
No
No
Yes
No
No

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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K032134 000
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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 Record Status

5b698295-c2a4-4d28-a1c3-ace539b2499d
July 06, 2018
3
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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