Esculin Reagent - 1% Ferric Ammonium Citrate

Basic Information

• Brand Name: Esculin Reagent - 1% Ferric Ammonium Citrate
• Primary DI: 00810048900534
• Version / Model: AS-713
• Catalog Number: AS-713
• Company Name: ANAEROBE SYSTEMS
• Labeler DUNS: 021192653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-01
• Public Version: 1
• Public Version Date: 2020-05-11
• Public Version Status: New
• Public Device Record Key: 88c94a89-da64-44b9-a795-70bf0a225c6f

Device Description

AS-713 Esculin Reagent is intended for use in the Esculin Hydrolysis Test for detection of esculin hydrolysis by anaerobic bacteria. 30 mL fill volume. 30 mL dropping bottle. 1 bottle per pack.

Device Characteristics

• Single Use: No
• 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
50414	Multiple anaerobic bacteria species culture isolate identification IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the differentiation and/or identification of one or multiple species of anaerobic bacteria isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810048900534	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius