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Anti-Beta 2 Glycoprotein Screen ELISA

Model 35-B2SHU-E01 · AMERICAN LABORATORY PRODUCTS COMPANY, LTD. · DI B24235B2SHUE010

MSV — System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) · Class II · 21 CFR 866.5660

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

01112023-03: 0 reports for this device; peer average 1/device03
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0301
This device (reports/month)Average device in MSV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

  • NAI 2015-11-09 American Laboratory Products Company, Ltd. · 0 citations
  • NAI 2015-11-09 American Laboratory Products Company, Ltd. · 0 citations