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510(k) Data Aggregation
K Number
K232864Device Name
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
Manufacturer
Date Cleared
2024-01-26
(133 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
Nantong Egens Biotechnology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EGENS Pregnancy Test Midstream I is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
EGENS Pregnancy Test Midstream II is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
Device Description
EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and are designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The only difference between EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II is the plastic casing. The device is in a ready-to-use format.
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