Healgen Scientific LLC
United Statesfrom the FDA registration address FDA establishment FEI 3009238284
- Devices
- 21
- Registrations
- FDA
- FDA recalls
- 11 ongoing
Catalogue
Search and filter all 21 devicesCompany details
- FDA FEI number
- 3009238284
- Address
- 3818 Fuqua St, Houston, TX, 77047
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 22 Aug 2024 Z-3303-2024 Class II Ongoing The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.
Frequently asked questions
How many devices does HEALGEN SCIENTIFIC LLC have in the registry?
The registry currently lists 21 devices for HEALGEN SCIENTIFIC LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list HEALGEN SCIENTIFIC LLC's devices?
Among its 21 most recently registered devices, HEALGEN SCIENTIFIC LLC has devices listed in FDA 510(k) (21 devices).
What risk classes do HEALGEN SCIENTIFIC LLC's devices fall under?
Among its 21 most recently registered devices, the classes recorded for HEALGEN SCIENTIFIC LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for HEALGEN SCIENTIFIC LLC?
FDA recall records list 1 recall initiated by HEALGEN SCIENTIFIC LLC, the most recent initiated on 22 Aug 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from HEALGEN SCIENTIFIC LLC in the registry?
The most recently registered devices listed for HEALGEN SCIENTIFIC LLC include Healgen URS Test Strips, Healgen® URS Test Strips, 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) and HEALGEN THC ONE STEP MARIJUANA TEST, HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST.