SPOTCHEM™ II HDL-Cholesterol

Basic Information

• Brand Name: SPOTCHEM™ II HDL-Cholesterol
• Primary DI: 00015482771225
• Version / Model: 77122
• Company Name: ARKRAY USA, INC.
• Labeler DUNS: 008171162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f5e7455d-e8b2-43b4-8afc-aff53bc48bbf

Device Description

Strip Description:  For the in vitro quantitative determination of HDL-Cholesterol in human plasma from whole blood samples.

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: 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
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL	Clinical Chemistry	862.1175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43440	Dry clinical chemistry analyser IVD, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple general clinical chemistry analytes, including electrolytes [e.g., sodium (Na+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine, liver enzymes [e.g. Lactate dehydrogenase (LDH), alkaline phosphatase (ALP)] and/or lipids and lipoproteins. It functions by measuring the amount of light reflected from strips or laminated film impregnated with dry reagents onto which a clinical specimen is placed. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00015482771225	GS1
Unit of Use	50015482771220	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K042443	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius