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Sign in to claim this brandScimedx Corp.
US
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?
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.
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 4 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EBV VCA IgG 10 wl; 10 pk | I-EBV01X | FDA UDI | Class I | Active |
| HSV 2 10 Well; 10 pk | I-HV201X | FDA UDI | Class II | Active |
| MeDiCa | 4001-48-M | FDA UDI | Class II | Active |
| MeDiCa | 8034-48-M | FDA UDI | Class II | Active |
| E.histolytica Antibody 96 Test with Calibrator | EH-96C | FDA UDI | Class II | Active |
| EBV EA 10 Well; 10 pk | I-EBV03X | FDA UDI | Class I | Active |
| MeDiCa | 0301-M | FDA UDI | Class II | Active |
| Echinococcus Antibody 96 Tests | EG-96 | FDA UDI | Class I | Active |
| L.pneu 1-6 IFA Poly(HT)180Test | 7184 | FDA UDI | Class II | Active |
| R. STR Test(L) 48 | 5848RL | FDA UDI | Class II | Active |
| CMA(MH) 48 Test(L) | 5448L | FDA UDI | Class II | Active |
| R. Rickettsii 12 well; 10 pk | I-RRS01X | FDA UDI | Class I | Active |
| MeDiCa | 8021-200 | FDA UDI | Class II | Active |
| TA(MT)96 Test(L) | 5096L | FDA UDI | Class II | Active |
| R. STR Test(L) 96 | 5896RL | FDA UDI | Class II | Active |
| GBM P KDY Test(L) 96 | 5696L | FDA UDI | Class II | Active |
| P ADN Pack 8 WELL | 6408 | FDA UDI | Class II | Active |
| Scanlisa C3d Elisa 96 Test | C3196 | FDA UDI | Class II | Active |
| MeDiCa | 3001-96-M | FDA UDI | Class II | Active |
| MeDiCa | 0402-M | FDA UDI | Class II | Active |
| P ADN Pack 4 WELL | 6401 | FDA UDI | Class II | Active |
| R. HRT Pack 8 WELL | 5428 | FDA UDI | Class II | Active |
| Autoscreen II 96 Test(L) | 2196L | FDA UDI | Class II | Active |
| STR Muscle Test(L) 48 | 5848L | FDA UDI | Class II | Active |
| R. KDY/STM Pack 8 WELL | 2308 | FDA UDI | Class II | Active |
| CMA RT HRT Test(L) 96 | 5496RL | FDA UDI | Class II | Active |
| ANA MS. LVR 48 Test | 11048L | FDA UDI | Class II | Active |
| MeDiCa | 0834-M | FDA UDI | Class II | Active |
| R. LVR/KDY/STM Pack 8 WELL | 2138 | FDA UDI | Class II | Active |
| MeDiCa | 4001-48 | FDA UDI | Class II | Active |
| Rpr Dry Control, 10 Test | 104-100/10 | FDA UDI | Class II | Active |
| L. pneu 1-6 DFA 20 Test(L) | 700L | FDA UDI | Class II | Active |
| MeDiCa | 6001-96-MI | FDA UDI | Class II | Active |
| C-ANCA 60 Test(L) | A060L | FDA UDI | Class II | Active |
| MeDiCa | 6001-96-ESD-R | FDA UDI | Class II | Active |
| Syphilis Rpr Liquid Test, 500 | 201-302/500 | FDA UDI | Class II | Active |
| E.histolytica Antibody 96Tests | EH-96 | FDA UDI | Class II | Active |
| MeDiCa | 8031-96-C2 | FDA UDI | Class II | Active |
| L.pneu 1-6(S) 18 Well(HT) | 7101 | FDA UDI | Class II | Active |
| HSV 1 IgG 120 Test Kit | I-HV101G | FDA UDI | Class II | Active |
| Rpr Dispensing Bottle Assembly | 400-110 | FDA UDI | Class II | Active |
| M. KDY/STM Auto Pack 8 WELL | 2318A | FDA UDI | Class II | Active |
| M. LVR Pack 4 WELL | 1011 | FDA UDI | Class II | Active |
| MeDiCa | 3001-48 | FDA UDI | Class II | Active |
| Chlamydia Trachomatis IgG 120 Test Kit | I-CTR01G | FDA UDI | Class I | Active |
| MeDiCa | 8031-400 | FDA UDI | Class II | Active |
| R. Conorii 12 well; 10 pk | I-RCI01X | FDA UDI | Class I | Active |
| MeDiCa | 1001-48 | FDA UDI | Class II | Active |
| EDL (ME) Test(L) 48 | 5348EL | FDA UDI | Class II | Active |
| P ESG Pack 8 WELL | 5308 | FDA UDI | Class II | Active |
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