PreciControl Release Syphilis

Basic Information

• Brand Name: PreciControl Release Syphilis
• Primary DI: 07613336183007
• Version / Model: 09366903190
• Catalog Number: 09366903190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-05
• Public Version: 1
• Public Version Date: 2023-10-13
• Public Version Status: New
• Public Device Record Key: 971dd521-6ff3-4858-a0eb-71141651dbf7

Device Description

PreciControl Release Syphilis

Device Characteristics

• Single Use: No
• 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
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37733	Treponema pallidum total antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336183007	GS1

Premarket Submissions

Submission Number	Supplement Number
BK230839	0