ISOLATOR™ 1.5 mL Microbial Tubes

Basic Information

• Brand Name: ISOLATOR™ 1.5 mL Microbial Tubes
• Primary DI: 10811877010958
• Version / Model: 50C5
• Company Name: Alere Scarborough, Inc.
• Labeler DUNS: 154148498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-23
• Public Version: 2
• Public Version Date: 2023-09-12
• Public Version Status: Update
• Public Device Record Key: 4d70b86d-5665-45f9-a9aa-e3a427b22c9a
• Distribution End Date: 2024-09-30

Device Description

The ISOLATOR 1.5 mL microbial tube is intended for use in the collection of small volume pediatric blood samples to be used in the isolation of microorganisms.

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIO	Device, Specimen Collection	Microbiology	866.2900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61165	Blood cell lysis reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811877010958	GS1

Premarket Submissions

Submission Number	Supplement Number
K832246	000