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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: —
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DUNS Number: —

Catalogue (285)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
ANA(HEp2) 300 Test(L)	H300L	FDA UDI	Class II	Active
MeDiCa	0832-M	FDA UDI	Class II	Active
P. Edl Pack 4 Well	5301E	FDA UDI	Class II	Active
M. KDY Pack 4 WELL	2011	FDA UDI	Class II	Active
MeDiCa	0842-RM	FDA UDI	Class II	Active
Anti-Reticulin IgA Antibody(L) Test	5796AL	FDA UDI	Class II	Active
MeDiCa	0822	FDA UDI	Class II	Active
MeDiCa	6001-400-ESD	FDA UDI	Class II	Active
HSV 2 IgG 120 Test Kit	I-HV201G	FDA UDI	Class II	Active
MeDiCa	6001-48-TA	FDA UDI	Class II	Active
M. KDY/STM Pack 8 WELL	2318	FDA UDI	Class II	Active
MeDiCa	8021-96-SD	FDA UDI	Class II	Active
ANA MS LVR 96 Test	11096L	FDA UDI	Class II	Active
Toxocara Antibody 96 Tests	TC-96	FDA UDI	Class II	Active
SMA(MsS)96 Test(L)	31096L	FDA UDI	Class II	Active
Lpneu Gr.1 IFA(HT) 180 Test	7182	FDA UDI	Class II	Active
Autoscreen 200 Test(L)	21200L	FDA UDI	Class II	Active
Trichinella Antibody 96 Tests	TN-96	FDA UDI	Class I	Active
MeDiCa	8021-96	FDA UDI	Class II	Active
SMA(MsS)48 Test(L)	31048L	FDA UDI	Class II	Active
MeDiCa	0302	FDA UDI	Class II	Active
ICA(MP) 96 Test(L)	5596L	FDA UDI	Class II	Active
Rpr Bulk Antigen Suspension 3x3	201-610	FDA UDI	Class II	Active
MeDiCa	2001-96	FDA UDI	Class II	Active
MeDiCa	8021-48-M	FDA UDI	Class II	Active
CMA(RH) 48 Test(L)	5448RL	FDA UDI	Class II	Active
L.pneu 1-6 IFA Poly(HT)60 Test	7160	FDA UDI	Class II	Active
Rpr Needles & Sheath, 20 Ga	400-120	FDA UDI	Class II	Active
L. pneu 1-6C/Specimen Slide	7000	FDA UDI	Class II	Active
TA(MT)48 Test(L)	5048L	FDA UDI	Class II	Active
M. LVR/KDY/STM Pack 4 WELL	3131	FDA UDI	Class II	Active
MeDiCa	8031-96-C1	FDA UDI	Class II	Active
Anti-Reticulin IgA 48 Test(L)	5748AL	FDA UDI	Class II	Active
M. KDY Pack 8 WELL	2018	FDA UDI	Class II	Active
P-ANCA 6 Well Slide	A006P	FDA UDI	Class II	Active
Chlamydia Trachomatis 10wl 10 pk	I-CTR01X	FDA UDI	Class I	Active
HSV 1 10 Well; 10 pk	I-HV101X	FDA UDI	Class II	Active
ANA(R LVR)48 Test	1048L	FDA UDI	Class II	Active
L.pneu 1-6/bdglmj/C Specimen Slide	7000C	FDA UDI	Class II	Active
MeDiCa	0831	FDA UDI	Class II	Active
MeDiCa	8021-48	FDA UDI	Class II	Active
MeDiCa	5001-96-M	FDA UDI	Class II	Active
MeDiCa	0301	FDA UDI	Class II	Active
M. STM Pack 8 WELL	3018	FDA UDI	Class II	Active
MeDiCa	2001-48	FDA UDI	Class II	Active
M. KDY/STM Pack 4 WELL	2311	FDA UDI	Class II	Active
ProSorb-G 2 ml 50 Test	CB004	FDA UDI	Class I	Active
MA MS KDYTest(L) 48 Test	21048L	FDA UDI	Class II	Active
MeDiCa	8031-48-M	FDA UDI	Class II	Active
DNA(C. luciliae) 50 Test(L)	6050L	FDA UDI	Class II	Active

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