Arvolife Fertility Kit
Arvolife Fertility Kit is a Class II device made by Clinical Guard, listed in FDA GUDID since 27 Mar 2018 (UDI-DI 00851950008048), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851950008048 | Date27 Mar 2018 | StatusListed |
Official records
- AccessGUDID record 00851950008048
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Arvolife
- Generic name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
- Model / reference
- Fertility Kit
- Primary DI / UDI-DI
- 00851950008048
- FDA product code
- LCX, NGE
- GMDN term
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
- Device class
- Class II
- Regulation number
- 862.1155, 862.1485
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter).
- Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream by Weihai Kangzhou Biotechnology Engineering Co., Ltd
- MYSET PREGNANCY TEST by Ani Biotech OY
- PREG-Q EARLY PREGNANCY TEST by Yd Diagnostics
- KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST by Koreamedico Co., Ltd.
- ACON MIDSTREAM PREGNANCY TEST by Acon Laboratories, Inc.
- HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) by HEALGEN SCIENTIFIC LLC
- HCG MIDSTREAM PREGNANCY TEST by Mizuho USA, Inc.
- ABBOTT ADVISOR ONE-STEP PREGNANCY TEST by Abbott Laboratories
- HOMECLINIC ONE STEP PREGNANCY TEST by Vanguard Biomedical Corp.
- ADVANCED QUALITY PREGNANCY TEST by Bionike, Inc.