N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398027175
• Version / Model: ML1
• Catalog Number: ML1
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-03
• Public Version: 1
• Public Version Date: 2020-06-11
• Public Version Status: New
• Public Device Record Key: c7a04844-ba8c-48f9-bdc7-dc8c404608b7

Device Description

McFarland Standard, Latex Equivalent # 1, 8ml fill, 16x100mm tube The McFarland Latex Standards are prepared from suspensions of uniform latex particles with similar absorbance values as the original barium sulfate standards.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
JTA	Monitor, Microbial Growth	Microbiology	866.2560	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	00819398027175	GS1

Customer Contacts

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

Storage Conditions

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