Northeast Laboratory Services

Basic Information

• Brand Name: Northeast Laboratory Services
• Primary DI: 00810144911007
• Version / Model: 1
• Catalog Number: T1475
• Company Name: Northeast Laboratory Services, Inc.
• Labeler DUNS: 071749709
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-08
• Public Version: 1
• Public Version Date: 2023-12-18
• Public Version Status: New
• Public Device Record Key: 81c073f8-2dc8-44e6-976a-96896fb12ab9

Device Description

Indole Broth

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSF	Culture Media, Single Biochemical Test	Microbiology	866.2320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34018	Indole broth/peptone water microbial reagent IVD	A substance or reactant, sometimes referred to as indole broth or peptone water, intended to be used in the testing of a microorganism isolated from a clinical specimen by culture, to detect the presence of enzymes that split indole from the amino acid tryptophan.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810144911007	GS1