N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398028714
• Version / Model: Z51
• Catalog Number: Z51
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-08-07
• Public Version: 2
• Public Version Date: 2023-12-20
• Public Version Status: Update
• Public Device Record Key: 7bb1e62b-87b6-48ba-8497-cfacc5c14185
• Distribution End Date: 2023-12-19

Device Description

Beta Lactamase Test, acidometric method, 20 tests per package An rapid acidometric method for performing a beta-lactamase test on Haemophilus spp., S. aureus, and N. gonorrhoeae. Easy to read, clear cut color change, just add bacteria and water to tube. Not for use with anaerobes.

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
64046	Beta-lactamase activity IVD, kit, mass spectrometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the hydrolytic activity of a beta-lactamase enzyme (e.g., carbapenemase) in a clinical specimen, using a mass spectrometry method. This test is used to detect bacteria that are resistant to beta-lactam antibiotics such as penicillin, cephalosporin, or carbapenem (e.g., Enterobacterales, Pseudomonas spp., Acinetobacter spp.).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819398026307	GS1
Primary	00819398028714	GS1

Customer Contacts

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

Storage Conditions

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