Identity
- Trade Name
- iFlash-Progesterone FDA UDI
- Generic Name
- Progesterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- C86030 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912718918 FDA UDI
- FDA Product Code
- JLS FDA UDI
- GMDN Term
- Progesterone IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Progesterone IVD, kit, chemiluminescent immunoassay
iFlash-Progesterone by Shenzhen YHLO Biotech Co., Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Progesterone IVD, kit, chemiluminescent immunoassay.
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- Progesterone Luminescence Immunoassay — IBL International GmbH · Class I
- Progesterone AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class I
- Alinity — ABBOTT IRELAND · Class I
- Elecsys Progesterone III — Roche Diagnostics Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen YHLO Biotech Co., Ltd.
Sources (2)
- FDA UDI e739a686-118f-46db-bd34-adb260394458 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026