DAYE (ANNE'S DAY LTD) · 89-08 · UNITED KINGDOM
For DAYE (ANNE'S DAY LTD), import alert is 89-08; country is UNITED KINGDOM; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit) | Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit); product code is 80 P - - WC General wellness product | 85 H - - EB Tampon, Menstrual, Unscented; date published is 07/17/2025; address is Biscuit Factory Business Complex , 100 Drummond Road , London, SWK UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- DAYE (ANNE'S DAY LTD) verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- UNITED KINGDOM verified
- Address
- Biscuit Factory Business Complex , 100 Drummond Road , London, SWK UNITED KINGDOM verified
- Date published
- 07/17/2025 verified
- Product code
- 80 P - - WC General wellness product | 85 H - - EB Tampon, Menstrual, Unscented each item verified
- Product
- Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit) | Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit) each item verified
What the source says
DAYE (ANNE'S DAY LTD) Date Published : 07/17/2025 Biscuit Factory Business Complex , 100 Drummond Road , London, SWK UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
80 P - - WC General wellness product Date Published: 08/06/2026 Desc: Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit) 85 H - - EB Tampon, Menstrual, Unscented Date Published: 07/17/2025 Desc: Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html