Audit MicroControls Linearity FD D-Dimer PATHFAST Immunoanalyzer

Basic Information

• Brand Name: Audit MicroControls Linearity FD D-Dimer PATHFAST Immunoanalyzer
• Primary DI: B085K883M50
• Version / Model: K883M-5
• Company Name: AALTO SCIENTIFIC
• Labeler DUNS: 077974989
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-27
• Public Version: 1
• Public Version Date: 2018-04-27
• Public Version Status: New
• Public Device Record Key: 2060014b-028b-4636-bd25-0e89260a307f

Device Characteristics

• Single Use: No
• 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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
47347	D-dimer 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 D-dimer protein in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B085K883M50	HIBCC