QuickProfile™ HCG Test Strip

Basic Information

• Brand Name: QuickProfile™ HCG Test Strip
• Primary DI: M90107RD70010
• Version / Model: 07RD7001
• Catalog Number: 07RD7001
• Company Name: LUMIQUICK DIAGNOSTICS, INC.
• Labeler DUNS: 790175165
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-15
• Public Version: 3
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: 297a3292-d061-47df-a530-bc4111d4aa05

Device Description

immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG)

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: 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
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54216	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M90107RD70011	HIBCC	PACK	50	In Commercial Distribution
Primary	M90107RD70010	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K981770	000

Device Sizes

Type	Value	Unit	Text
Length	72	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius