AnaeroGRO

Basic Information

• Brand Name: AnaeroGRO
• Primary DI: 00819398020114
• Version / Model: AG24H
• Catalog Number: AG24H
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-05-13
• Public Version: 2
• Public Version Date: 2024-02-06
• Public Version Status: Update
• Public Device Record Key: de8ae432-d459-464b-9faf-84b55639d973
• Distribution End Date: 2024-02-05

Device Description

Peptone Yeast Extract Glucose Broth, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Diagnostics AnaeroGRO™ Peptone Yeast Extract Glucose Broth (PYG) is an enriched, non-selective medium recommended for the cultivation and biochemical identification of obligately anaerobic microorganisms. This medium is also suitable for the growth of anaerobic bacteria to be identified by gas liquid chromatography (GLC) analysis as outlined by the CDC.

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
JSC	Culture Media, General Nutrient Broth	Microbiology	866.2350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58687	Enriched broth culture medium IVD	A broth culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms, from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow in a general-purpose broth medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819398020107	GS1
Primary	00819398020114	GS1

Customer Contacts

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