Advance Dx Blood Collection Card: Single strip cards - no lines on the front

Basic Information

• Brand Name: Advance Dx Blood Collection Card: Single strip cards - no lines on the front
• Primary DI: 00860013988067
• Version / Model: CMT01.8
• Catalog Number: CMT01.8
• Company Name: ADVANCE DX, INC.
• Labeler DUNS: 041235184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-03
• Public Version: 1
• Public Version Date: 2026-03-11
• Public Version Status: New
• Public Device Record Key: 4a1a69a8-9aec-4c83-ba3c-6076a1eb7215

Device Description

Advance Dx Blood Collection Card - Single strip cards. No lines on the front

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: 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
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63134	Dried blood spot collection kit IVD	A collection of devices and materials intended to be used by a healthcare professional at the point-of-care to collect a dried blood spot (DBS) specimen from capillary or venous blood, for subsequent diagnostic testing or screening. The kit typically includes a lancet and/or hypodermic needle with a syringe, capillary tube(s), 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). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860013988064	GS1	Pack	25	In Commercial Distribution
Primary	00860013988067	GS1

Customer Contacts

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