Identity
- Trade Name
- Nuvetest FDA UDI
- Generic Name
- Vaginal pH screening IVD, kit, rapid colorimetric, clinical FDA UDI
- Model / Reference
- F-1-VS-EX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290006558173 FDA UDI
- 510(k) Number
- K091287 FDA UDI
- FDA Product Code
- CEN FDA UDI
- GMDN Term
- Vaginal pH screening IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal pH screening IVD, kit, rapid colorimetric, clinical
Nuvetest by Peptonic Medical Israel Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal pH screening IVD, kit, rapid colorimetric, clinical.
- Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- Exploro Vaginal Health pH Test Device — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- Testahead Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- Exploro Vaginal Health pH Test Device — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- Safecare Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- GoldN Easy to Use Vaginal pH Test — NOVODX Corporation · Class I
- Gynex — GYNEX CORPORATION · Class I
- Welcheck Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
Cleared under the same submission
K091287 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Peptonic Medical Israel Ltd
Sources (1)
- FDA UDI 5499c4c3-52b0-455e-9fbe-df3eea9b4c6f 33 fields · synced Jun 1, 2026