DAVID - This product is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 3 midstreams in one box.
2026-06-01
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005216656 | 3005216656 | Equinox Biotech Co., Ltd. | 1 | N | 2026-01-01 | Rongsheng Technological Zone UNIVERSITY ROAD, Shantou Guangdong CN 515063 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850014758363 | NATALIST - NATALIST EARLY Pregnancy Test is a self-testing rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. There are 4pcs of midstream in each box. | 1-843-5807572 | liz@natalist.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 24176 | 1720427024 | K991067 | MODIFICATION OF: DAVIDSTRIP HCG | JHI | 1999-04-27 |
| 24176 | 1708654541 | K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette | LCX | 2019-02-22 |
| 24176 | 1129059335 | K172627 | David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette | LCX | 2018-03-28 |
| 24176 | 1133121996 | K053236 | DAVID PREGNANCY TEST (MIDSTREAM) | LCX | 2006-07-18 |
| 24176 | 1377097296 | ||||
| 24176 | 1474531027 | ||||
| 24176 | 1867066770 | ||||
| 24176 | 1971611848 |
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