BD Macro-Vue™ Card Test Rotator

Basic Information

• Brand Name: BD Macro-Vue™ Card Test Rotator
• Primary DI: 00382902780519
• Version / Model: 278051
• Catalog Number: 278051
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-19
• Public Version: 4
• Public Version Date: 2023-12-05
• Public Version Status: Update
• Public Device Record Key: 15ce7747-e9a7-4654-a1f0-e2f5021d8a6a

Device Description

BD Macro-Vue™ Card Test Rotator

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51819	Treponema pallidum reagin antibody IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382902780519	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Depth	8	Inch
Width	7	Inch
Height	5.25	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 65 Degrees Celsius