RegWardenFDA facility compliance records
Facility

UNISTRIP TECHNOLOGIES, LLC

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2014: 1 recalls; 2019: 1 inspections1’14’15’16’17’181’19’20’21’22’23’24’25’26
  • Recalls (1)
  • Inspections (1)

Devices registered here (2)

  • System, Test, Blood Glucose, Over The Counter
    Product code NBW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345
  • Glucose Oxidase, Glucose
    Product code CGA (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345

Recalls & enforcement

FDA inspections (1)

  • NAI2019-05-01
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “UNISTRIP TECHNOLOGIES, LLC (FEI 3010622184) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010622184-unistrip-technologies-llc/

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