N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00816576027125
• Version / Model: J82
• Catalog Number: J82
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-06-23
• Public Version: 1
• Public Version Date: 2020-07-01
• Public Version Status: New
• Public Device Record Key: 01e1e117-3674-4c39-b527-62463bb0fe56

Device Description

Haemophilus ID Quadplate, for Haemophilus ID Quadplate consists of four separate formulations, which supply the requirements as follows: RTF Casman Medium, Modified (X- and V-factors) Tryptic Soy Agar (TSA) with Hemin (X-factor) Tryptic Soy Agar (TSA), modified with NAD (V-factor) Chocolate Agar (X- and V-factors) For the differentiation of Haemophilus spp.X and V Factors, 15x100mm quadplate, order by the package of 10

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: No
• 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
JSH	Culture Media, Non-Selective And Differential	Microbiology	866.2320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58585	Differential/selective agar culture medium IVD	An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816576027118	GS1
Primary	00816576027125	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K870636	000

Storage Conditions

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