LW Scientific

Basic Information

• Brand Name: LW Scientific
• Primary DI: 00664816001769
• Version / Model: CTL-DIFD-08KP
• Company Name: LW SCIENTIFIC, INC.
• Labeler DUNS: 785335381
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-23
• Public Version: 3
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 41b6a3a4-563f-4cb6-b681-74e5ae4d814a

Device Description

8 Key Digital Differential Counter

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GHO	Hemocytometer	Hematology	864.6160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64080	White blood cell differential count recorder IVD, powered	An electrically-powered device intended to be used by a healthcare professional to manually record and display haematological cell counts of white blood cell populations in a clinical specimen, as observed under a microscope. It typically consists of buttons representing each white blood cell type (e.g., basophil, eosinophil, lymphocyte) which the operator depresses to record an observed cell type, and a screen to display each cell population count. It may also automatically calculate cell population percentages and allow for corrections in case of a miscount.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00664816001769	GS1