AccessGUDID - DEVICE: Rapid Response (00722066001646)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid Response
Version or Model: TSH-13C20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSH-13C20
Company Name: BTNX Inc

Primary DI Number: 00722066001646
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 251005005 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030912	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7faf1112-0890-4223-83a2-ed47af810ea2
Public Version Date: April 20, 2023
Public Version Number: 4
DI Record Publish Date: October 25, 2016