K-QUE-KED-001 REV000

GUDID 00850054552129

QCard Collection Kit

Quest Diagnostics

Capillary blood collection set, home-use

• Primary Device ID: 00850054552129
• NIH Device Record Key: d843e965-115a-41bc-96d9-2572b3be7add
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-QUE-KED-001 REV000
• Version Model Number: K-QUE-KED-001 REV000
• Company DUNS: 189222334
• Company Name: Quest Diagnostics
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850054552129 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-05
• Device Publish Date: 2026-02-25

Devices Manufactured by Quest Diagnostics

• 00850054552068 - K-QUE-ACT-001 REV002: 2026-03-05 QCard Blood Collection Kit (WHS)
• 00850054552075 - K-QUE-ACT-003 REV002: 2026-03-05 QCard Collection Kit (WHS)
• 00850054552082 - K-QUE-ACT-004 REV002: 2026-03-05 QCard Collection Kit
• 00850054552099 - K-QUE-ACT-005 REV002: 2026-03-05 QCard Collection Kit (WHS)
• 00850054552105 - K-QUE-ACT-006 REV001: 2026-03-05 QCard Collection Kit (WHS)
• 00850054552112 - K-QUE-ACT-007 REV000: 2026-03-05 QCard Collection Kit (WHS)
• 00850054552129 - K-QUE-KED-001 REV000: 2026-03-05QCard Collection Kit
• 00850054552129 - K-QUE-KED-001 REV000: 2026-03-05 QCard Collection Kit
• 10850054552034 - US Blood And Urine Kit: 2024-05-09 US Blood And Urine Kit