Molecular Testing Labs

Basic Information

• Brand Name: Molecular Testing Labs
• Primary DI: 00860008357892
• Version / Model: Dried Blood Spot, Urine, and Swab Collection Kit
• Company Name: Blackfly Investments, LLC
• Labeler DUNS: 069497839
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-16
• Public Version: 1
• Public Version Date: 2024-09-24
• Public Version Status: New
• Public Device Record Key: ca8ada41-8d4c-4450-ac2f-3520f6798224

Device Description

Dried Blood Spot, Urine, and Swab Collection Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.	No	Active
58177	Urine specimen collection kit IVD	A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.	No	Active
66256	Dried blood spot collection card IVD	A device intended to be used for dried blood spot collection and preservation, at the point-of-care, for subsequent diagnostic testing or screening. It is typically in the form of paper integrated in a card, on which a whole blood specimen is applied and absorbed onto the collection paper. The card may include a form to capture patient demographic information This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008357892	GS1