Device
QCard Collection Kit K-QUE-ACT-001-PR is a collection kit that will be distributed in Puerto Rico. This kit is the same as K-QUE-ACT-001 with the difference that it includes a prod...
Manufacturer
Quest Diagnostics
Quest Diagnostics
Model: K-QUE-ACT-001-PR
DI: 00850054552136
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-18
Description
QCard Collection Kit K-QUE-ACT-001-PR is a collection kit that will be distributed in Puerto Rico. This kit is the same as K-QUE-ACT-001 with the difference that it includes a product insert/instructions that are in Spanish.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
2fc98958-90f2-46b0-9725-da99573326b2
Distribution Status:
In Commercial Distribution
DUNS Number:
189222334
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850054552136
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38092
Name: Capillary blood collection set, home-use
Definition:
A collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and, in some cases, mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet(s), a blood storage device [e.g., collection strip, dry blood collection card/filter paper card, vial] and other items (e.g., alcohol prep pad, gauze pad, bandage strip, a container with a requisition form for mailing to the laboratory); some types may alternatively be in the form of a skin-attached self-contained unit and may feature a blood drawing suction mechanism. This is a single-use device.
FDA Product Codes
None