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CRYOcheck™ Abnormal 1 Reference Control

Model ARP1-05 · Precision Biologic Inc · DI 00843876000077

GGC — Control, Plasma, Abnormal · Class II · 21 CFR 864.5425

GGN — Plasma, Coagulation Control · Class II · 21 CFR 864.5425

UDILibrary device dossier · generated 2026-09-16 · 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.

01112021-03: 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)
2021-0301
This device (reports/month)Average device in GGC, GGN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Precision Biologic Inc

  • NAI 2017-02-02 Precision Biologic Inc · 0 citations
  • NAI 2017-02-02 Precision Biologic Inc · 0 citations