ADAM

Basic Information

• Brand Name: ADAM
• Primary DI: 08809317541006
• Version / Model: ADAM-rWBC Kit
• Catalog Number: ADHK-050
• Company Name: NanoEnTek, Inc.
• Labeler DUNS: 687910463
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-15
• Public Version: 1
• Public Version Date: 2021-02-23
• Public Version Status: New
• Public Device Record Key: cba2a2ed-ebd4-4ace-a0e3-feaba777826c

Device Description

It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC HT.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
GKZ	Counter, Differential Cell	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55859	White blood cell count IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809317541006	GS1

Premarket Submissions

Submission Number	Supplement Number
BK200525	0