DEVICE: MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) (B126KR62100)

Download: XML | JSON

Device Identifier (DI) Information

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
KR6210
KR6210
KRONUS, INC.
B126KR62100
HIBCC
1
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid peroxidase (TPO) receptor in human serum.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, radioimmunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroid peroxidase (anti-TPO); also known as anti-microsomal antibody, in a clinical specimen, using a radioimmunoassay method.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JZO System, Test, Thyroid Autoantibody
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 23, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-457-6687
kronus@kronus.com
CLOSE