N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398027212
• Version / Model: Z61
• Catalog Number: Z61
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: a9878ee4-2c86-41c7-9f0d-69bc181449bd

Device Description

Bile Spot Test, Deoxycholate 10%, for Streptococcus pneumoniae, rapid spot test for pneumococci, 15ml each Sodium desoxycholate 10%, use to identify S. pneumoniae, colonies will autolyze in the presence of bile salts. Store in refrigerator, warm before use. Recommended for use in presumptively differentiating bile soluble Streptococcus pneumoniae from bile insoluble alpha-hemolytic Streptococcus spp. The bile solubility test may be performed using a cell suspension or by applying the Bile Spot Reagent directly to the colony.

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
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42735	Bile solubility microbial reagent IVD	A substance or reactant, sometimes referred to as sodium deoxycholate reagent, intended to be used in microbial testing for the presumptive identification of Streptococcus pneumoniae by determining the solubility of suspect colonies isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819398027212	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius