K-QUE-ACT-005 REV002

Basic Information

• Brand Name: K-QUE-ACT-005 REV002
• Primary DI: 00850054552099
• Version / Model: K-QUE-ACT-005 REV002
• Company Name: Quest Diagnostics
• Labeler DUNS: 189222334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-25
• Public Version: 1
• Public Version Date: 2026-03-05
• Public Version Status: New
• Public Device Record Key: e33411b6-ae68-49f3-8823-f9c450146412

Device Description

QCard Collection Kit (WHS)

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: 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

GMDN Terms

Code	Name	Definition	Implantable	Status
38092	Capillary blood collection set, home-use	A collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory); some types may be in the form of a self-contained unit featuring a suction mechanism. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850054552099	GS1