Aptiva® APS IgM Controls

Basic Information

• Brand Name: Aptiva® APS IgM Controls
• Primary DI: 08430793040914
• Version / Model: 725142
• Company Name: INOVA DIAGNOSTICS, INC.
• Labeler DUNS: 188354831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-11
• Public Version: 1
• Public Version Date: 2024-03-19
• Public Version Status: New
• Public Device Record Key: 0eab9ea1-70d7-472b-af74-9eefcce60ce5

Device Description

1. Aptiva APS IgM Contros 1 (2x0.5mL) 2.Aptiva APS IgM Control 2 (2x0.5mL)

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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41280	Anticardiolipin 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 one or multiple classes of antibodies to cardiolipin in a clinical specimen.	No	Active
46025	Anticardiolipin-B2-glycoprotein I complex antibody IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin-B2-glycoprotein I complex in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08430793040914	GS1

Customer Contacts

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

Storage Conditions

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