CT Neonatal hTSH 1000 Kit

Basic Information

• Brand Name: CT Neonatal hTSH 1000 Kit
• Primary DI: 00817830022573
• Version / Model: 07-294306
• Catalog Number: 07-294306
• Company Name: MP BIOMEDICALS, LLC
• Labeler DUNS: 137825928
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ad282fa3-9ced-4695-ba08-530810c57d48

Device Description

For the quantitative determination of TSH in Neonatal Blood.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JLW	RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE	Clinical Chemistry	862.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54385	Thyroid stimulating hormone (TSH) IVD, kit, radioimmunoassay	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 a radioimmunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817830022573	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	43.18	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius