Chrysalis Intelligence · Sponsors · Healgen Scientific,, LLC

Healgen Scientific,, LLC

Houston, TX, US · 13 510(k) clearances · 1 recalls

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Total clearances

13

2022-03-16 → 2026-04-13

Last 12 months

5

Product codes

10

Most recent

2026-04-13

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
NGL	Test, Opiates, Over The Counter	Class II	Clinical Toxicology	4	2025-12-23
QYT	Over-The-Counter Covid-19 Antigen Test	Class II	Microbiology	1	2026-04-13
DJC	Thin Layer Chromatography, Methamphetamine	Class II	Clinical Toxicology	1	2026-03-16
NFW	Test, Cannabinoid, Over The Counter	Class II	Clinical Toxicology	1	2026-02-12
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Class I	Clinical Chemistry	1	2025-12-23
DJG	Enzyme Immunoassay, Opiates	Class II	Clinical Toxicology	1	2025-08-15
QVF	—	—	—	1	2024-04-19
LJX	Test, Urine Leukocyte	Class I	Hematology	1	2023-06-16
LDJ	Enzyme Immunoassay, Cannabinoids	Class II	Clinical Toxicology	1	2023-03-17
GTY	—	—	—	1	2022-03-16

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2024-08-22

Date	Severity	Status	Recall #	Product	Code	Reason
2024-08-22	Class II	Ongoing	Z-3303-2024	Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is emp…	—	The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential fals…

Filings

All 510(k) clearances (13)

Date	K-number	Device	Code	Class	Specialty
2026-04-13	K260095	Heal-Check Rapid COVID-19 Antigen Self-Test	QYT	Class II	Microbiology
2026-03-16	K253705	Healgen® Accurate Oral Fluid Drug Test	DJC	Class II	Clinical Toxicology
2026-02-12	K252523	Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test	NFW	Class II	Clinical Toxicology
2025-12-23	K253567	Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card	NGL	Class II	Clinical Toxicology
2025-12-23	K251800	Healgen® URS Test Strips	JMT	Class I	Clinical Chemistry
2025-08-15	K251972	Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)	DJG	Class II	Clinical Toxicology
2024-12-17	K243365	Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup	NGL	Class II	Clinical Toxicology
2024-05-13	K240949	Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)	NGL	Class II	Clinical Toxicology
2024-04-19	K232377	Healgen Rapid COVID-19 Antigen Test	QVF	—	—
2024-04-12	K240686	Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card	NGL	Class II	Clinical Toxicology
2023-06-16	K231045	Healgen URS Test Strips	LJX	Class I	Hematology
2023-03-17	K223162	Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT	LDJ	Class II	Clinical Toxicology
2022-03-16	K212623	Healgen Strep A Rapid Test Strip (Throat Swab)	GTY	—	—