DEVICE: STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KIT (B126KR60100)
Device Identifier (DI) Information
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KIT
KR6010
In Commercial Distribution
KR6010
KRONUS, INC.
KR6010
In Commercial Distribution
KR6010
KRONUS, INC.
A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
53789 | Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen, using a radioimmunoassay method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PCG | 21-Hydroxylase Antibody (21-Ohab) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K121046 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
82ed935a-5e4f-4823-8cac-fd2b07d6bfaf
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-457-6687
kronus@kronus.com
kronus@kronus.com