HCG midstream Test

Basic Information

• Brand Name: HCG midstream Test
• Primary DI: 00840239028228
• Version / Model: RAP-2822
• Catalog Number: RAP-2822
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-20
• Public Version: 5
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: d495889b-bb8e-40c3-ba0d-c262ed835e58
• Distribution End Date: 2021-09-15

Device Description

This is a test for the qualitative detection of human Chorionic Gonadotropin (HCG) in urine.

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
LCX	KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54019	Human chorionic gonadotropin beta-subunit/follicle stimulating hormone IVD, kit, rapid ICT, clinical	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) and follicle stimulating hormone (FSH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses for the detection of pregnancy. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840239028228	GS1

Customer Contacts

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