CLIAWAIVED INC

Basic Information

• Brand Name: CLIAWAIVED INC
• Primary DI: 00816610020402
• Version / Model: THYROCHEK-120-A-KIT
• Catalog Number: THYROCHEK-120-A-KIT
• Company Name: Cliawaived, Inc.
• Labeler DUNS: 969635304
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-29
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: b70b23a1-5626-4e27-a607-5992c7e8a92e

Device Description

Thyrochek One-Step Whole Blood Rapid TSH Assay

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
63175	Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of thyroid stimulating hormone (TSH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment, as an indicator of TSH levels.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816610020402	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]