N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00810047420576
• Version / Model: 6052
• Company Name: Scientific Device Laboratory, Inc.
• Labeler DUNS: 115927956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-31
• Public Version: 1
• Public Version Date: 2023-02-08
• Public Version Status: New
• Public Device Record Key: 890ee49c-3cc6-4487-9788-e10ecb6378de

Device Description

Fecal Parasite Concentrators 15ml [100 concentrators/case]

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJH	Clinical Sample Concentrator	Clinical Chemistry	862.2310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57939	Faecal parasite specimen concentration kit IVD	A collection of devices intended to be used for the concentration and recovery of eggs, larvae, and cysts of intestinal parasites (e.g., pinworms) from a faecal specimen, for microscopic analysis and/or other investigation. The kit typically includes reagents, centrifuge tubes, and filters. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810047420576	GS1