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510(k) Data Aggregation
K Number
K230741Device Name
Macro & Micro-Test HCG Pregnancy Test Midstream
Manufacturer
Date Cleared
2023-10-13
(210 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
**Jiangsu Macro **& Micro-Test Med-Tech Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Macro & Micro-Test HCG Pregnancy Test Midstream is intended for over-the-counter use for qualitative detection of hCG hormone in urine to aid early detection of pregnancy.
Device Description
Macro & Micro-Test HCG Pregnancy Test Midstream is a qualitative lateral flow test for the detection of hCG (human chorionic gonadotropin) hormone, which is present in urine during the early stage of pregnancy. The midstream kits consist of one test device and a package insert. The test device contains mouse monoclonal anti- B hCG antibody coated membrane and a pad containing mouse monoclonal anti- a -hCG antibody colloidal gold conjugate. The control antibodies are goat anti-rabbit IgG.
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