C1q Plates & Calibrator Sets

Basic Information

• Brand Name: C1q Plates & Calibrator Sets
• Primary DI: 00813545023744
• Version / Model: C1QCP
• Catalog Number: C1QCP
• Company Name: SCIMEDX CORPORATION
• Labeler DUNS: 155424708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 4
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 41ca0032-a4e8-42fe-952a-271ebf305fa9

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
DAK	Complement C1q, Antigen, Antiserum, Control	Immunology	866.5240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53673	Complement component C1q IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade component C1q in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used for the characterization and/or diagnosis of complement cascade component C1q deficiency, which may be associated with systemic lupus erythematosus (SLE) and glomerulonephritis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813545023744	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K833636	000