ADVIA Centaur® PTH

Basic Information

• Brand Name: ADVIA Centaur® PTH
• Primary DI: 00630414592398
• Version / Model: 10699160
• Catalog Number: 10699160
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-11-12
• Public Version: 7
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: c86e7f0a-eef6-4857-967a-fe8ebed6cf0e

Device Description

Intact parathyroid hormone (iPTH) - 500 tests - 5PK -REF2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• 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
CEW	RADIOIMMUNOASSAY, PARATHYROID HORMONE	Clinical Chemistry	862.1545	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54277	Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of parathyroid hormone (PTH) [intact, whole, or truncated fragments] in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414592398	GS1
Unit of Use	00630414017242	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: store up right, protect from light, resuspend.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius