Human C4 Control Pack for use on the SPAPLUS®

Basic Information

• Brand Name: Human C4 Control Pack for use on the SPAPLUS®
• Primary DI: 05051700018869
• Version / Model: NQ025.S
• Company Name: THE BINDING SITE GROUP LIMITED
• Labeler DUNS: 347045614
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-05
• Public Version: 3
• Public Version Date: 2023-08-04
• Public Version Status: Update
• Public Device Record Key: f4efe8f4-62a4-4bac-9412-34010560a6de
• Distribution End Date: 2023-06-01

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31471	Complement components C4/C4c IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of complement cascade components C4 and/or C4c in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051700018869	GS1

Customer Contacts

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

Storage Conditions

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