Identity
- Trade Name
- Ansh Labs DBS Luteinizing Hormone ELISA FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Dried Blood Spot Luteinizing hormone (LH) immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Luteinizing hormone (LH). It is intended for in vitro diagnostic use. FDA UDI
- Model / Reference
- AL-190-i FDA UDI
- Description
- The Dried Blood Spot Luteinizing hormone (LH) immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Luteinizing hormone (LH). It is intended for in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- AL-190-i FDA UDI
- Primary DI / UDI-DI
- 00853592008325 FDA UDI
- GMDN Term
- Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA)
Ansh Labs DBS Luteinizing Hormone ELISA by Ansh Labs, LLC — 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
- 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Ansh Labs, LLC
Sources (1)
- FDA UDI dfc3ce90-03a0-4708-ac26-e47598bb390f 34 fields · synced Jun 6, 2026