Identity
- Trade Name
- Natalist Ovulation Test FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Natalist Ovulation Test is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. There are 7pcs of 6mm midstreams in each box. FDA UDI
- Model / Reference
- 82221 FDA UDI
- Description
- Natalist Ovulation Test is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. There are 7pcs of 6mm midstreams in each box. FDA UDI
Identifiers
- Catalog Number
- RH-LH-B FDA UDI
- Primary DI / UDI-DI
- 00860001730210 FDA UDI
- FDA Product Code
- NGE FDA UDI
- GMDN Term
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1485 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Natalist Ovulation Test by Equinox Biotech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical.
- AMPLIM — AMPLIM, LLC · Class II
- AMPLIM — AMPLIM, LLC · Class II
- INSTANT-VIEW LH Ovulation Predicting Cassette Test — Alfa Scientific Designs, Inc. · Class I
- Mosie Baby Ovulation Test — GERMAINE LABORATORIES, INC. · Class I
- FERTICARE — Weihai Kangzhou Biotechnology Engineering Co., Ltd · Class I
- Modern Fertility Ovulation Test — MODERN HEALTH · Class I
- Natural Cycles — Natural Cycles Nordic AB · Class II
- OvuSign® LH card — PRINCETON BIOMEDITECH CORP. · Class I
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 |
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Manufacturer
- Manufacturer
- Equinox Biotech Co., Ltd.
Sources (1)
- FDA UDI 3525b558-cc47-45f3-a0ee-7d478dd39766 35 fields · synced May 29, 2026