Identity
- Trade Name
- LAPL™ aB2GPI IgM HRP ELISA Kit FDA UDI
- Generic Name
- Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- LAPL™ aB2GPI IgM HRP ELISA Kit for detection of IgM anti-B2 Glycoprotein I Antibodies. FDA UDI
- Model / Reference
- IgM FDA UDI
- Description
- LAPL™ aB2GPI IgM HRP ELISA Kit for detection of IgM anti-B2 Glycoprotein I Antibodies. FDA UDI
Identifiers
- Catalog Number
- LAPL-K-HRP-AB2GPI-1M FDA UDI
- Primary DI / UDI-DI
- B473LAPLKHRPAB2GPI1M0 FDA UDI
- GMDN Term
- Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
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: Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
LAPL™ aB2GPI IgM HRP ELISA Kit by Louisville Apl Diagnostics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA).
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- QUANTA LITE® B2 GPI IgA ELISA Bulk Pack Kit (Lab Corp) — INOVA DIAGNOSTICS, INC. · Class II
- QUANTA Lite® β2GPI IgG ELISA — INOVA DIAGNOSTICS, INC. · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- QUANTA Lite® β2GPI Screening ELISA — INOVA DIAGNOSTICS, INC. · Class II
- QUANTA Lite® β2GPI IgM ELISA — INOVA DIAGNOSTICS, INC. · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
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
- Louisville Apl Diagnostics, Inc.
Sources (1)
- FDA UDI 167f9dbb-8a5b-41fa-8d79-420991577d76 35 fields · synced May 30, 2026