AimStrip Tandem Lipid Profile and glucose measuring system

Basic Information

• Brand Name: AimStrip Tandem Lipid Profile and glucose measuring system
• Primary DI: 00695684773014
• Version / Model: ILM-0001A
• Company Name: GERMAINE LABORATORIES, INC
• Labeler DUNS: 176458115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-13
• Public Version: 3
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 4efcb199-ffff-49f3-97c5-f29659b56c41

Device Description

Lipid and Glucose Measuring System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	862.1175	1
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	862.1705	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52849	Glucose/ketone/lipid profile IVD, kit, enzyme chemiluminescence	A collection of reagents and other associated materials intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile, using an enzyme chemiluminescence method.	No	Obsolete
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	No	Active
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active
53359	Total cholesterol lipid IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cholesterol lipid in a clinical specimen, using a spectrophotometry method.	No	Active
44697	Total cholesterol lipid IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total cholesterol lipid in a clinical specimen.	No	Active
44701	Triglyceride IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of triglycerides in a clinical specimen.	No	Active
53460	Triglyceride IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of triglycerides in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00695684773014	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130295	000