API® McFarland Standard

Basic Information

• Brand Name: API® McFarland Standard
• Primary DI: 03573026100087
• Version / Model: 70900
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-10
• Public Version: 1
• Public Version Date: 2020-04-20
• Public Version Status: New
• Public Device Record Key: 821f2f39-2987-4c4a-922d-fe0c03ca8aec

Device Description

McFarland Standard is a series of standards of different opacity, allowing the estimation of the density of bacterial suspensions.

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: 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JTO	DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62854	McFarland standard IVD	A standard solution intended to be used as a reference in the estimation of the number of bacteria in a suspension based on the turbidity, compared to that of the McFarland standard. It consists of specified volumes of barium chloride and sulphuric acid. The standard is typically used to adjust the inoculum in microbial assays (e.g., microbial susceptibility and microbial identification) where a standardized inoculum is required.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03573026100087	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius