N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398026390
• Version / Model: Z81
• Catalog Number: Z81
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-06-16
• Public Version: 1
• Public Version Date: 2020-06-24
• Public Version Status: New
• Public Device Record Key: 583e349c-2591-45cb-a48e-f25c1b4da189

Device Description

Bovine Serum Albumin 0.2%, 3ml each, for enhanced growth of mycobacteria; optically clear, shatter resistant, polycarbonate tube, 20 per kit Used for the preparation of specimens for AFB culture. A growth stimulant for Mycobacterium tuberculosis.

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
JSK	Supplement, Culture Media	Microbiology	866.2450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62160	Culture medium nutrient supplement IVD	A formulation of non-selective supplements containing nutrients e.g., (amino acids, sugars, minerals) or other additives (e.g., serum, haemoglobin) intend to enrich a culture medium to sustain and/or enhance the growth or isolation of a specific target microbial species from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819398026383	GS1
Primary	00819398026390	GS1

Customer Contacts

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

Storage Conditions

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