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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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Catalogue (285)

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Device	Model / Reference	Registries	Class	Status
O. Tsutsugamushi(Scrub Typhus) 12 well; 10 pk	I-OTS01X	FDA UDI	Class I	Active
Rickettsia typhi 12 well;10 pk	I-RTY01X	FDA UDI	Class I	Active
Schistosoma Antibody 96 Tests	SCHISTO-96	FDA UDI	Class I	Active
ANCA 6 Well Slide	A006	FDA UDI	Class II	Active
P. Thr Pack 4 Well	5001	FDA UDI	Class II	Active
MeDiCa	0834	FDA UDI	Class II	Active
Autoscreen I MS KDY/STM 48 Test	1248L	FDA UDI	Class II	Active
R. STM/STR/HRT Pack 4W	1381	FDA UDI	Class II	Active
MeDiCa	0608-MI	FDA UDI	Class II	Active
Scanlisa C1q Elisa 96 Test	C1196	FDA UDI	Class II	Active
R. Prowazekii 12 well; 10 pk	I-RPR01X	FDA UDI	Class I	Active
MeDiCa	0822-M	FDA UDI	Class II	Active
Measles IgG 120 Test Kit	I-MEA01G	FDA UDI	Class I	Active
MeDiCa	8031-96	FDA UDI	Class II	Active
ANA R LVR 96 Test	1096L	FDA UDI	Class II	Active
P HRT Pack 8 WELL	5408	FDA UDI	Class II	Active
M. LVR Pack 8 WELL	1018	FDA UDI	Class II	Active
RSV IgG 120 Test Kit	I-RSV01G	FDA UDI	Class I	Active
MeDiCa	0833	FDA UDI	Class II	Active
HEp2 Slide + control wl 5 WELL	1005	FDA UDI	Class II	Active
C. burnetii 12 Well 10 pk	I-QFB01X	FDA UDI	Class I	Active
Ifa Hep2 Kit For The Detection Of Antinuclear Antibodies	K970198	FDA 510(k)	Class II	Active
Scimedx Phase Ii Pr3 Igg Antibody Eia	K010287	FDA 510(k)	Class II	Active
Scimedx Phase Ii Mpo Igg Antibody Eia	K010289	FDA 510(k)	Class II	Active
Ifa Kit For The Detection Of C-Anca Antibodies	K962360	FDA 510(k)	Class II	Active
Eia Kit For The Detction Of Anti-Pr3 Antibodies	K954105	FDA 510(k)	Class II	Active
Eia Kit For The Detection Of Anti-Mpo Antibodies	K954062	FDA 510(k)	Class II	Active
Eurospital Eu-Ttg Iga Umana	K010625	FDA 510(k)	Class II	Active
Gliadin Iga Antibody Eia Detection System	K002169	FDA 510(k)	Class II	Active
Eu-Ttg Iga Elisa	K994379	FDA 510(k)	Class II	Active
Tpo Igg Antibody Eia Test	K011082	FDA 510(k)	Class II	Active
Gliadin Igg Antibody Eia Detection System	K002189	FDA 510(k)	Class II	Active
Phase Ii Gbm Igg Antibody Eia Test	K011348	FDA 510(k)	Class II	Active
Ifa Kit For The Detection Of Endomysial Iga Anibodies Using Primate Umbilical Cord (puc)-Ema/Puc Lga.	K002107	FDA 510(k)	Class II	Active
Eia Kit For The Detection Of Gbm Antibodies	K953495	FDA 510(k)	Class II	Active

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