Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The LH ELISA is intended for the quantitative determination of luteinizing hormone (LH) in human serum. This assay is useful in the diagnosis and treatment of gonadal dysfunction. 96 Tests. FDA UDI
- Model / Reference
- F1031-96 FDA UDI
- Description
- The LH ELISA is intended for the quantitative determination of luteinizing hormone (LH) in human serum. This assay is useful in the diagnosis and treatment of gonadal dysfunction. 96 Tests. FDA UDI
Identifiers
- Catalog Number
- F1031-96 FDA UDI
- Primary DI / UDI-DI
- 00811727013262 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
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, enzyme immunoassay (EIA)
Pointe Scientific, Inc. by Pointe Scientific, 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
- 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
- LH ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · 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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 81a37ec3-4dd2-4ca6-a194-8fa497701aab 36 fields · synced May 30, 2026