Pregnancy (hCG) Rapid Test Midstream

Basic Information

• Brand Name: Pregnancy (hCG) Rapid Test Midstream
• Primary DI: 06970277512404
• Version / Model: FHC-103H
• Catalog Number: FHC-103H
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• Labeler DUNS: 543254717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-05
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: e0937480-b883-406f-bc4c-35e54b8a35a4

Device Description

Pregnancy (hCG) Rapid Test Midstream

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54210	Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen using an enzyme immunoassay (EIA) method. It is used to aid detection of pregnancy, or as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970277512404	GS1