Medtest DX
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Medtest DX is a medical device manufacturer, with 74 devices listed in FDA GUDID and FDA 510(k) (FDA Class I and II) and 1 FDA recall as of 14 Nov 2026.
- Devices
- 74
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 72
- FDA 510(k) 2
- Device classes
- FDA Class I 38
- FDA Class II 35
- FDA recalls
At a glance
Market reach
- United States
- FDA recalls
What Medtest DX makes
Medtest DX manufactures in vitro diagnostic (IVD) controls and reagent kits for laboratory testing, including enzyme spectrophotometry-based assays for alanine aminotransferase (ALT) and urea. Their product line also covers human chorionic gonadotropin beta-subunit (beta-HCG) controls and enzyme immunoassay reagents for drug metabolite detection, such as cocaine metabolites.
The company’s devices are regulated under FDA Class I and Class II classifications, with submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) registries.
Catalogue
Search and filter all 74 devicesShowing 1-50 of 74
FDA recalls
FDA recall records list 1 recall initiated by Medtest DX, initiated on 2015-05-15. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 15 May 2015 Z-2768-2015 Class II Terminated Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end.
Frequently asked questions
How many devices does Medtest DX have in the registry?
The registry currently lists 74 devices for Medtest DX. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtest DX's devices?
Among its 50 most recently registered devices, Medtest DX has devices listed in FDA GUDID (50 devices).
What risk classes do Medtest DX's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Medtest DX's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medtest DX?
FDA recall records list 1 recall initiated by Medtest DX, the most recent initiated on 15 May 2015. 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 Medtest DX in the registry?
The most recently registered devices listed for Medtest DX include Wash Concentrate 3 10W500, Albumin / BS480 ALB480, MedTest DX Total Protein for the BS200 TP600 and MedTest DX Elevated HCG Control Vial Label - B HCGCTLB.