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QuikScreen

Model 60A41 · SYNTRON BIORESEARCH, INC. · DI 00748349000342

DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites · Class II · 21 CFR 862.3250

DIS — Enzyme Immunoassay, Barbiturate · Class II · 21 CFR 862.3150

DJC — Thin Layer Chromatography, Methamphetamine · Class II · 21 CFR 862.3610

DJD — Enzyme Immunoassay, Primidone · Class II · 21 CFR 862.3680

DJG — Enzyme Immunoassay, Opiates · Class II · 21 CFR 862.3650

DJR — Enzyme Immunoassay, Methadone · Class II · 21 CFR 862.3620

DKZ — Enzyme Immunoassay, Amphetamine · Class II · 21 CFR 862.3100

JXN — Enzyme Immunoassay, Propoxyphene · Class II · 21 CFR 862.3700

LCM — Enzyme Immunoassay, Phencyclidine

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.

12232019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 3/device01020506071007060406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0501
2019-0601
2019-0701
2019-1002
2021-0701
2022-0601
2026-0401
2026-0603
This device (reports/month)Average device in DIO, DIS, DJC, DJD, DJG, DJR, DKZ, JXN, LCM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — SYNTRON BIORESEARCH, INC.

  • Warning Letter 2010-05-24 Syntron Bioresearch Inc
  • Warning Letter 2010-05-24 Syntron Bioresearch Inc
  • VAI 2025-06-02 Syntron Bioresearch Inc · 2 citations
  • VAI 2025-06-02 Syntron Bioresearch Inc · 2 citations
  • VAI 2021-10-14 Syntron Bioresearch Inc · 4 citations
  • VAI 2021-10-14 Syntron Bioresearch Inc · 4 citations
  • VAI 2016-07-15 Syntron Bioresearch Inc · 3 citations
  • VAI 2016-07-15 Syntron Bioresearch Inc · 3 citations
  • VAI 2011-04-01 Syntron Bioresearch Inc · 2 citations
  • VAI 2011-04-01 Syntron Bioresearch Inc · 2 citations
  • OAI 2010-11-30 Syntron Bioresearch Inc · 6 citations
  • OAI 2010-11-30 Syntron Bioresearch Inc · 6 citations
  • OAI 2010-01-21 Syntron Bioresearch Inc · 10 citations
  • OAI 2010-01-21 Syntron Bioresearch Inc · 10 citations