CalSet PTH

Basic Information

• Brand Name: CalSet PTH
• Primary DI: 04015630940776
• Version / Model: 07360894190
• Catalog Number: 07360894190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-17
• Public Version: 5
• Public Version Date: 2020-11-27
• Public Version Status: Update
• Public Device Record Key: 838585b6-92b7-41de-8184-258aa7fd6b7b
• Distribution End Date: 2019-04-29

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
JIT	CALIBRATOR, SECONDARY	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42207	Parathyroid hormone (PTH) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of parathyroid hormone (PTH) [intact, whole, or truncated fragments] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630940776	GS1

Storage Conditions

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