DEVICE: Rapid Response (00722066001646)
Device Identifier (DI) Information
Rapid Response
TSH-13C20
In Commercial Distribution
TSH-13C20
BTNX Inc
TSH-13C20
In Commercial Distribution
TSH-13C20
BTNX Inc
Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are for the qualitative detection of TSH in serum, plasma or whole blood.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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Yes | |
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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? |
---|---|---|---|---|
54383 | Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JLW | Radioimmunoassay, Thyroid-Stimulating Hormone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K030912 | 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
7faf1112-0890-4223-83a2-ed47af810ea2
April 20, 2023
4
October 25, 2016
April 20, 2023
4
October 25, 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:
00722066004319
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined