Identity
- Trade Name
- iFlash-LH EUDAMEDFDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- iFlash-LH EUDAMED
- Model / Reference
- C86010-L EUDAMEDC86010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912711797 EUDAMED06925912718925 FDA UDI
- Basic UDI-DI
- 692591270011GN EUDAMED
- FDA Product Code
- CEP FDA UDI
- EMDN Code
- W0102050105 LUTEINISING HORMONE EUDAMED
- GMDN Term
- Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1485 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
iFlash-LH 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 Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay.
- ADVIA Centaur® LH — Siemens Healthcare Diagnostics · Class I
- Alinity — ABBOTT IRELAND · Class I
- Elecsys LH — Roche Diagnostics Corp. · Class I
- ADVIA Centaur® LH — Siemens Healthcare Diagnostics · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
- Alinity — ABBOTT IRELAND · Class I
- IMMULITE® 2000 Systems LH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Dimension Vista® Flex® reagent cartridge LH — Siemens Healthcare Diagnostics · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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 4b2b612e-8611-4075-bf12-cf9b3e99a247 32 fields · synced Jul 9, 2026
- EUDAMED e794c6df-2328-45f0-aa6b-51014871ac89 61 fields · synced Jul 9, 2026