MicroVue

Basic Information

• Brand Name: MicroVue
• Primary DI: 30014613333944
• Version / Model: PTH EIA
• Catalog Number: 8044
• Company Name: QUIDEL CORPORATION
• Labeler DUNS: 079509836
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2023-06-30
• Public Version Status: Update
• Public Device Record Key: 953a1524-1e87-46c5-8a78-09720b02aa85
• Distribution End Date: 2017-10-09

Device Description

MicroVue PTH EIA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
CEW	RADIOIMMUNOASSAY, PARATHYROID HORMONE	Clinical Chemistry	862.1545	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54280	Parathyroid hormone (PTH) 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 qualitative and/or quantitative detection of parathyroid hormone (PTH) [intact, whole, or truncated fragments] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613333944	GS1

Customer Contacts

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

Storage Conditions

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