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Scimedx Corp.

Last updated May 23, 2026

What Scimedx Corp. makes

Scimedx Corp. manufactures in vitro diagnostic (IVD) kits and fluorescent immunoassays for detecting various antibodies, including antinuclear antibodies (ANA), mitochondrial antibodies M2, smooth muscle antibodies, intrinsic factor/parietal cell antibodies, striated muscle antibodies, endomysium antibodies, Legionella pneumophila total antibodies, and multiple thyroid antibodies.

The company's devices are classified as Class I and Class II and are listed in the FDA 510(k) and FDA UDI registries. Scimedx Corp. is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Scimedx Corp. manufacture?

Where is Scimedx Corp. based?

Scimedx Corp. is based in the United States, as indicated by the country designation in the device data.

Which regulatory registries list Scimedx Corp.'s devices?

Scimedx Corp.'s devices are listed in the FDA 510(k) and FDA UDI (Unique Device Identification) registries, as specified in the device data.

How are Scimedx Corp.'s devices classified?

Scimedx Corp.'s devices are classified as Class I and Class II, which are regulatory classifications that determine the level of control required to ensure the safety and effectiveness of the devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (285)

Page 2 of 6

Device	Model / Reference	Registries	Class	Status
DNA 10 Well Slide	6010	FDA UDI	Class II	Active
MeDiCa	8021-400-M-P-R	FDA UDI	Class II	Active
MeDiCa	6001-48-ES	FDA UDI	Class II	Active
Mumps IgG 120 Test Kit	I-MUV01G	FDA UDI	Class I	Active
R. LVR Pack 4 WELL	1001	FDA UDI	Class II	Active
MeDiCa	5001-96	FDA UDI	Class II	Active
P-ANCA 60 Test(L)	A060PL	FDA UDI	Class II	Active
MeDiCa	0831-M	FDA UDI	Class II	Active
L.pneu Gr.1(Mono)(HT) 18 Well	7105	FDA UDI	Class II	Active
MeDiCa	0101	FDA UDI	Class II	Active
P KDY Pack 4 WELL	5601	FDA UDI	Class II	Active
MeDiCa	8031-400-M-RA	FDA UDI	Class II	Active
MeDiCa	8034-96-M	FDA UDI	Class II	Active
Autoscreen I 48 Test(L)	1148L	FDA UDI	Class II	Active
R. LVR/KDY/STM Pack 4 WELL	2131	FDA UDI	Class II	Active
L.pneuGR1-6&Mic.Screen(HT)18W	CLEGMIC	FDA UDI	Class II	Active
P. Esg Pack 4 Well	5301	FDA UDI	Class II	Active
Rickettsia rickettsii (RMSF) Latex 30 Test Ki	L-RRS01T	FDA UDI	Class I	Active
MeDiCa	8031-400-NPBS	FDA UDI	Class II	Active
MeDiCa	8021-96-M-P	FDA UDI	Class II	Active
MeDiCa	4001-96	FDA UDI	Class II	Active
MeDiCa	0608-TA	FDA UDI	Class II	Active
Endomysial(ME)96 Test(L)	5396EL	FDA UDI	Class II	Active
MeDiCa	8033-48	FDA UDI	Class II	Active
MeDiCa	0608-ESD	FDA UDI	Class II	Active
MeDiCa	6001-48-ESD-C1	FDA UDI	Class II	Active
C1q Plates & Calibrator Sets	C1QCP	FDA UDI	Class II	Active
MeDiCa	6001-48-ESD	FDA UDI	Class II	Active
MeDiCa	8031-48	FDA UDI	Class II	Active
MeDiCa	5001-48-M	FDA UDI	Class II	Active
P. EDL Pack 8 WELL	5308E	FDA UDI	Class II	Active
ANA(HEp2)Test(L) 60 Test	1060L	FDA UDI	Class II	Active
P HRT Pack 4 WELL	5401	FDA UDI	Class II	Active
Measles 10 Well; 10 pk	I-MEA01X	FDA UDI	Class I	Active
DNA 5 Well Slide Pack	6005	FDA UDI	Class II	Active
MeDiCa	8021-200-M	FDA UDI	Class II	Active
MeDiCa	8034-48	FDA UDI	Class II	Active
R. LVR Pack 8 WELL	1008	FDA UDI	Class II	Active
MeDiCa	8021-96-M	FDA UDI	Class II	Active
MeDiCa	0832	FDA UDI	Class II	Active
RSV 10 Well; 10 pk	I-RSV01X	FDA UDI	Class I	Active
MBO IgG Test System	MBO396	FDA UDI	Class II	Active
L.pneu 1-6(S) 6 Well Slide	7023	FDA UDI	Class II	Active
Anti-ADN Test(L) 48	6448L	FDA UDI	Class II	Active
DNA(C. luciliae) 100 Test(L)	6100L	FDA UDI	Class II	Active
MeDiCa	6001-96-ES	FDA UDI	Class II	Active
R. HRT/STR Pack 4 WELL	5481	FDA UDI	Class II	Active
L. pneu 1-6/bdglmj DFA Screen	700SC	FDA UDI	Class II	Active
Ehrlichia chaffeensis 12wl; 10 pk	I-ECH01X	FDA UDI	Class I	Active
MeDiCa	8031-400-M	FDA UDI	Class II	Active

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