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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)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
Syphilis RPR Liquid Test, Bulk 500 Test	201-302/500B	FDA UDI	Class II	Active
MeDiCa	5001-48	FDA UDI	Class II	Active
Autoscreen Ii Test System	2196LA	FDA UDI	Class II	Active
MeDiCa	0402	FDA UDI	Class II	Active
MeDiCa	6001-400-ESD-R	FDA UDI	Class II	Active
P PNC Pack 4 WELL	5501	FDA UDI	Class II	Active
P KDY Pack 8 WELL	5608	FDA UDI	Class II	Active
MeDiCa	8031-1600	FDA UDI	Class II	Active
M. LVR/KDY/STM Pack 8 WELL	3138	FDA UDI	Class II	Active
GBM IgG Test System	GBM396	FDA UDI	Class II	Active
MeDiCa	8031-200-M	FDA UDI	Class II	Active
MeDiCa	3001-48-M	FDA UDI	Class II	Active
Cytomegalovirus IgG 120 Tests	I-CMV01G	FDA UDI	Class II	Active
T.solium Antibody 96 Tests	TS-96	FDA UDI	Class I	Active
SMA(RS)48 Test(L)	3048L	FDA UDI	Class II	Active
EBV-VCA IgG 120 Test Kit	I-EBV01G	FDA UDI	Class I	Active
MeDiCa	6001-96-ESD	FDA UDI	Class II	Active
ANA(HEp2)120 Test(L)	1120L	FDA UDI	Class II	Active
C3d Plates & Calibrator Sets	C3DCP	FDA UDI	Class II	Active
MeDiCa	0604-ES	FDA UDI	Class II	Active
MA(RK)96 Test(L)	2096L	FDA UDI	Class II	Active
Anti-Reticulin IgG Antibody(L)	5796GL	FDA UDI	Class II	Active
M. STM Pack 4 WELL	3011	FDA UDI	Class II	Active
CAMPY (jcl) Latex 50 Test Kit	L-CAM01T	FDA UDI	Class I	Active
MeDiCa	6001-96-TA	FDA UDI	Class II	Active
Autoscreen I 96 Test(L)	1196L	FDA UDI	Class II	Active
Autoscreen II 48 Test(L)	2148L	FDA UDI	Class II	Active
P PNC Pack 8 WELL	5508	FDA UDI	Class II	Active
ASA(ME)48 Test(L)	5348L	FDA UDI	Class II	Active
MeDiCa	4001-96-M	FDA UDI	Class II	Active
MeDiCa	8033-48-M	FDA UDI	Class II	Active
Syphilis Rpr Liquid Test, 150	201-302/150	FDA UDI	Class II	Active
Anti-Reticulin IgG 48 Test(L)	5748GL	FDA UDI	Class II	Active
MeDiCa	0608-ES	FDA UDI	Class II	Active
MeDiCa	0302-M	FDA UDI	Class II	Active
MA(RK)48 Test(L)	2048L	FDA UDI	Class II	Active
Autoscreen II(Ms) 48 Test(L)	2248L	FDA UDI	Class II	Active
MeDiCa	0102	FDA UDI	Class II	Active
Leptospira IgG Antibody 96 Test	LEPTO-G	FDA UDI	Class II	Active
Filaria Antibody 96 Tests	FI-96	FDA UDI	Class I	Active
R. KDY Pack 4 WELL	2001	FDA UDI	Class II	Active
MA MS KDY Test(L) 96 Test	21096L	FDA UDI	Class II	Active
R. KDY/STM Pack 4 WELL	2301	FDA UDI	Class II	Active
MeDiCa	0833-M	FDA UDI	Class II	Active
Rbp Elisa Assay 96 Test Kit	RBP196	FDA UDI	Class I	Active
Autoscreen I MS KDY/STM 96 Test	1296L	FDA UDI	Class II	Active
MeDiCa	8031-48-C2	FDA UDI	Class II	Active
MeDiCa	0201	FDA UDI	Class II	Active
R. KDY Pack 8 WELL	2008	FDA UDI	Class II	Active
ICA(MP) 48 Test(L)	5548L	FDA UDI	Class II	Active

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