AmpliVue

Basic Information

• Brand Name: AmpliVue
• Primary DI: 30014613312147
• Version / Model: M214
• Catalog Number: M214
• Company Name: DIAGNOSTIC HYBRIDS, INC.
• Labeler DUNS: 117359612
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-28
• Public Version: 5
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 1b438baa-db17-4ddd-941e-cdb296547cd0

Device Description

AmpliVue Heatblock Insert

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
JRG	BLOCK, HEATING	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15105	Heating block IVD	An electrically-powered device which is primarily a heating element, with or without a thermostat, that is built into a compact block and intended to be used as a stable dry heat source to heat in vitro diagnostic specimens/laboratory materials. It is typically a stand-alone instrument, or an interchangeable component of an in vitro diagnostic instrument/analyser. It is available in various sizes to accommodate microplates of varying sizes, and may include covers to minimize evaporation from microplates.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613312147	GS1

Customer Contacts

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