MicroVue

Basic Information

• Brand Name: MicroVue
• Primary DI: 30014613333920
• Version / Model: BAP EIA
• Catalog Number: 8012
• Company Name: QUIDEL CORPORATION
• Labeler DUNS: 079509836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 3
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 1046ac92-de28-4ff0-b9fd-861ff99787d8

Device Description

MicroVue BAP 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
CIN	ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES	Clinical Chemistry	862.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66164	Bone alkaline phosphatase (BALP) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of bone alkaline phosphatase (BALP) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used as a marker for osteoblastic activity to aid in the diagnosis and/or management of metabolic bone diseases (e.g., osteoporosis, Paget’s disease).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613333920	GS1

Customer Contacts

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

Storage Conditions

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