PreKnow Pregnancy Test (25 hCG Strips)

Basic Information

• Brand Name: PreKnow Pregnancy Test (25 hCG Strips)
• Primary DI: 00857275007100
• Version / Model: ID1-S-25P
• Company Name: IDUN SOLUTIONS LLC
• Labeler DUNS: 080651010
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-16
• Public Version: 3
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 995bd9be-68ac-475e-ac90-af1e9756c82c

Device Description

25 Test Strips; hCG Test Strips

Device Characteristics

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

GMDN Terms

Code	Name	Definition	Implantable	Status
33819	Total human chorionic gonadotropin 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 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 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 to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). 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	00857275007100	GS1
Package	00857275007001	GS1	25 HCG Strips	25	In Commercial Distribution
Package	00857275007018	GS1	20 HCG Strips	20	In Commercial Distribution
Package	10857275007015	GS1	60 Kits	60	In Commercial Distribution
Package	10857275007008	GS1	120 Kits	120	In Commercial Distribution