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Medtest DX

Last updated May 23, 2026

Information

Country: US
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Catalogue (74)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Wash Concentrate 3	10W500	FDA UDI	Class I	Unknown
Albumin / BS480	ALB480	FDA UDI	Class II	Unknown
MedTest DX Total Protein for the BS200	TP600	FDA UDI	Class II	Unknown
MedTest DX Elevated HCG Control Vial Label - B	HCGCTLB	FDA UDI	Class I	Active
MedTest DX, Inc. Lipid Controls	LIPC480	FDA UDI	Class I	Unknown
Direct Lipid Control L2	3002	FDA UDI	Class I	Unknown
MedTest DX Control Level 1	HNC200	FDA UDI	Class I	Unknown
MedTest DX Total Protein for the BS480	TP480	FDA UDI	Class II	Unknown
Ast / Bs480	AST480	FDA UDI	Class II	Unknown
MedTest DX Lipoprotein (a) Calibrator	LPAC400	FDA UDI	Class II	Unknown
MedTest DX autoHDL for PC180	HDL505	FDA UDI	Class I	Unknown
MedTest DX Magnesium for the BS480	MAG480	FDA UDI	Class I	Unknown
MedTest DX Phosphorus Reagent for the BS480	PHO480	FDA UDI	Class I	Unknown
AST / Polychem 180	AST505	FDA UDI	Class II	Unknown
MedTest DX Wash Solution for the BS200	WS600	FDA UDI	Class I	Unknown
MedTest DX Triglycerides for the BS200	TRI600	FDA UDI	Class I	Unknown
Direct Lipid Control L1	3001	FDA UDI	Class I	Unknown
Calibration Serum Level 2	CA1400	FDA UDI	Class II	Unknown
MedTest DX autoHDL / BS200	HDL600	FDA UDI	Class I	Unknown
MedTest DX Homocysteine Controls	HOMQ480	FDA UDI	Class II	Unknown
MedTest DX Total Iron / BS480	IRO480	FDA UDI	Class I	Unknown
MedTest Dx, Inc. Lactate Dehydrogenase	LDH600	FDA UDI	Class II	Unknown
Albumin / BS200	ALB600	FDA UDI	Class II	Unknown
MedTest DX, Inc. Lipoprotein (a)	LPA400	FDA UDI	Class II	Unknown
MedTest DX HCG Control Set	HCG-CTL	FDA UDI	Class I	Active
MedTest DX Uric Acid for the BS480	UA480	FDA UDI	Class I	Unknown
Albumin	ALB505	FDA UDI	Class II	Unknown
Direct Lipid Control Set	3000	FDA UDI	Class I	Unknown
Alt / Bs480	ALT480	FDA UDI	Class I	Active
MedTest DX Elevated HCG Control Vial Label - A	HCGCTLA	FDA UDI	Class I	Active
Calcium / BS480	CAL480	FDA UDI	Class II	Unknown
MedTest DX Lactate Standard	LACS480	FDA UDI	Class II	Unknown
Alt / Bs200	ALT600	FDA UDI	Class I	Active
MedTest DX auto HDL/LDL Calibrator	HDLC480	FDA UDI	Class I	Unknown
MedTest DX Triglycerides for the BS480	TRI480	FDA UDI	Class I	Unknown
Ast / Bs200	AST600	FDA UDI	Class II	Unknown
MedTest DX Uric Acid for the BS200	UA600	FDA UDI	Class I	Unknown
MedTest DX Homocysteine	HOM480	FDA UDI	Class II	Unknown
MedTest Dx, Inc. autoLDL	LDL600	FDA UDI	Class I	Unknown
Bun/Bs480	BUN480	FDA UDI	Class II	Active
Wash Concentrate 1	03W500	FDA UDI	Class I	Unknown
MedTest DX Magnesium on the BS200	MAG600	FDA UDI	Class I	Unknown
MedTest DX Lactate Dehydrogenase / BS480	LDH480	FDA UDI	Class II	Unknown
Calibrator Level 1	CA1100	FDA UDI	Class II	Unknown
MedTest DX autoHD™L / BS480	HDL480	FDA UDI	Class I	Unknown
Amylase / BS200	AMY600	FDA UDI	Class II	Unknown
MedTest Dx, Inc. Lp (a)	LPA480	FDA UDI	Class II	Unknown
Wash Concentrate 2	09W500	FDA UDI	Class I	Unknown
MedTest Dx, Inc. Lipase (Colorimetric)	LIP600	FDA UDI	Class I	Unknown
Amylase / BS480	AMY480	FDA UDI	Class II	Unknown

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 15, 2015	Z-2768-2015	—	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.