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Sign in to claim this brandOrgenics, Ltd.
US
Last updated May 30, 2026
What Orgenics, Ltd. makes
Orgenics, Ltd. manufactures in vitro diagnostic (IVD) devices for the detection of HIV-1 and HIV-2 antigens and antibodies, including rapid immunochromatographic test kits and associated controls. The company also produces immunoassay test kits for the detection of IgG antibodies to pathogens such as Chlamydia trachomatis, cytomegalovirus (CMV), and Toxoplasma gondii under the ImmunoComb(TM) brand.
These devices are classified as Class I and Class II medical devices and are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identification (UDI) system. Orgenics, Ltd. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Orgenics, Ltd. make?
Orgenics, Ltd. manufactures in vitro diagnostic (IVD) devices for detecting HIV-1 and HIV-2 antigens and antibodies, including rapid immunochromatographic test kits and associated controls. The company also produces immunoassay test kits for detecting IgG antibodies to pathogens such as Chlamydia trachomatis, cytomegalovirus (CMV), and Toxoplasma gondii under the ImmunoComb(TM) brand.
Where is Orgenics, Ltd. based?
Orgenics, Ltd. is based in the United States, as stated in the device data summary.
Which registries list Orgenics, Ltd.'s devices?
Orgenics, Ltd.'s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identification (UDI) system, as specified in the device data under LISTED IN.
How are Orgenics, Ltd.'s devices classified?
Orgenics, Ltd.'s devices are classified as Class I and Class II medical devices, as indicated in the DEVICE CLASSES field of the device data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- alere.com
- —
- —
- [email protected]
- Phone
- (877)866-9335
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 600022628
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alere Determine HIV-1/2 Ag/Ab Combo Controls | Alere Determine HIV-1/2 Ag/Ab Combo Cont | FDA UDI | N/A | Active |
| Alere Determine HIV-1/2 Ag/Ab Combo | Alere Determine HIV-1/2 Ag/Ab Combo | FDA UDI | N/A | Active |
| Alere Determine HIV-1/2 Ag/Ab Combo | Alere Determine HIV-1/2 Ag/Ab Combo | FDA UDI | N/A | Active |
| Orgenics Immunocomb(tm) Chlamydia Trachomatis Igg | K895468 | FDA 510(k) | Class I | Active |
| Orgenics Immunocomb(tm) Cmv Igg Antibody Test Kit | K891393 | FDA 510(k) | Class II | Active |
| Immunocomb(tm) Toxoplasma Igg Antibody Test Kit | K885344 | FDA 510(k) | Class II | Active |
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