Identity
- Trade Name
- VIDAS® LH FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- VIDAS® LH (LH) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of LH concentration in human serum or plasma . FDA UDI
- Model / Reference
- 30406-01 FDA UDI
- Description
- VIDAS® LH (LH) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of LH concentration in human serum or plasma . FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026156930 FDA UDI
- 510(k) Number
- K921176 FDA UDI
- FDA Product Code
- CEP FDA UDI
- GMDN Term
- Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA) 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA)
Vidas® Lh by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA).
- LH-Urine ELISA — DRG International, Inc. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- Luteinizing Hormone (LH) ELISA — American Laboratory Products Company · Class I
- Ansh Labs Ultra-Sensitive Luteinizing Hormone ELISA — Ansh Labs, LLC
- LH-Serum ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- LH — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- LH AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class I
- Luteinizing Hormone ELISA (LH ELISA) (Urine) — American Laboratory Products Company · 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
- Biomerieux , Inc.
Sources (1)
- FDA UDI 25386b28-baff-40b9-a68a-7f0458777ef4 35 fields · synced May 30, 2026