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APL™ IgM ELISA Kit

FDA UDI

by Louisville Apl Diagnostics, Inc.

Identity

Trade Name
APL™ IgM ELISA Kit FDA UDI
Generic Name
Phospholipid antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The APL™ IgM ELISA Kit is designed for the measurement of anticardiolipin antibodies of the IgM isotype. FDA UDI
Model / Reference
IgM FDA UDI
Description
The APL™ IgM ELISA Kit is designed for the measurement of anticardiolipin antibodies of the IgM isotype. FDA UDI

Identifiers

Catalog Number
LAPL-K-AP-M-0 FDA UDI
Primary DI / UDI-DI
B473LAPLKAPM00 FDA UDI
GMDN Term
Phospholipid 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: Phospholipid antibody IVD, kit, enzyme immunoassay (EIA)

APL™ IgM ELISA Kit by Louisville Apl Diagnostics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Phospholipid antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Louisville Apl Diagnostics, Inc.

Sources (1)

  • FDA UDI 612b7a7e-c03e-4646-9110-e9fc6b149ae6 35 fields · synced Jun 7, 2026