Atellica CH Phencyclidine (PcpC)

Basic Information

• Brand Name: Atellica CH Phencyclidine (PcpC)
• Primary DI: 00630414654232
• Version / Model: 11701334
• Catalog Number: 11701334
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2025-10-15
• Public Version: 1
• Public Version Date: 2025-10-23
• Public Version Status: New
• Public Device Record Key: e708398f-fef8-4f99-924d-6e2b1ab702a3

Device Description

Phencyclidine (PcpC) - Atellica CH - RGT - 380T

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: 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
LCM	Enzyme immunoassay, phencyclidine	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
55745	Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of phencyclidine (PCP) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00630414322032	GS1
Primary	00630414654232	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K222439	000

Storage Conditions

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