Is this your brand? Sign in to claim ownership.
Sign in to claim this brandOrganon, Inc.
United States·US-MF-000037903
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 30 Hudson Street, Jersey City, New Jersey, United States
- Website
- www.organon.com
- —
- —
- [email protected]
- Phone
- +1 844 674 3200
- PRRC Contact
- Sylina Littlejohn
- EUDAMED SRN
- US-MF-000037903
- FDA FEI Number
- 3017425145
- DUNS Number
- —
Catalogue (50)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Follistim Aq Cartridge 600iu Sam | 1044800 | FDA UDI | Class II | Active |
| Follistim Aq Cartridge 300iu Sam | 1044801 | FDA UDI | Class II | Active |
| Follistim Aq Cartridge 300iu | 1044615 | FDA UDI | Class II | Active |
| Follistim Aq Cartridge 600iu | 1044616 | FDA UDI | Class II | Active |
| Follistim Pen Starter Kit Sam | 1044943 | FDA UDI | Class II | Active |
| Xaciato | 1048228 | FDA UDI | Class I | Active |
| Follistim Aq Cartridge 900iu | 1044617 | FDA UDI | Class II | Active |
| Follistim Pen Starter Kit | 1044942 | FDA UDI | Class II | Active |
| Reconstitution Accessoreis | K950861 | FDA 510(k) | Class II | Active |
| Quantaffirm Cpk Iso Enzyme Serum (human) | K791723 | FDA 510(k) | Class I | Active |
| Dasp Tm Anti-Rabbit | K770597 | FDA 510(k) | Class II | Active |
| Rapi-Dot | K802974 | FDA 510(k) | Class II | Active |
| Oreai-Q-Tu Test | K802464 | FDA 510(k) | Class II | Active |
| Accurate Beta 30 Pregnancy Test Kit | K841602 | FDA 510(k) | Class II | Active |
| Rheumanosticon R | K771410 | FDA 510(k) | Class II | Active |
| Quantrols Im | K771941 | FDA 510(k) | N/A | Active |
| Rubenosticon | K780063 | FDA 510(k) | Class II | Active |
| Quantrols Hcg | K772086 | FDA 510(k) | Class II | Active |
| Tubes, Hydrolysis, Calibrated | K770605 | FDA 510(k) | N/A | Active |
| Accurate Beta | K812967 | FDA 510(k) | Class II | Active |
| Rubanon | K790122 | FDA 510(k) | Class II | Active |
| Pregnosticon Pregnancy Test Kit | K790734 | FDA 510(k) | Class II | Active |
| Neo-Pregnosticon Duoclon Tube Test | K831339 | FDA 510(k) | Class II | Active |
| Oreia-Q-Ty, Enzyme Immunoassay | K802693 | FDA 510(k) | Class II | Active |
| Quantrols Rf | K771940 | FDA 510(k) | Class II | Active |
| B-Neocept | K812334 | FDA 510(k) | Class II | Active |
| Oreia-T4 | K780308 | FDA 510(k) | Class II | Active |
| Predictor | K780240 | FDA 510(k) | Class II | Active |
| Rad-291 | K781554 | FDA 510(k) | Class I | Active |
| Neocept | K811941 | FDA 510(k) | Class II | Active |
| B-Neocept 30 | K840650 | FDA 510(k) | Class II | Active |
| Duoclon Slide Test | K831109 | FDA 510(k) | Class II | Active |
| Oreia Ii, B-Hcg | K811940 | FDA 510(k) | Class II | Active |
| Monosticon Uni-Dot | K853388 | FDA 510(k) | Class II | Active |
| Oreia-Q-Dig | K802358 | FDA 510(k) | Class II | Active |
| Oreia Ii B-Hcg Pregnancy Test Kit | K841525 | FDA 510(k) | Class II | Active |
| Strepto-Sec Tm | K801159 | FDA 510(k) | Class I | Active |
| Liquaemib Sodium Preservative, Etc. | K771304 | FDA 510(k) | Class II | Active |
| Oreia-Tu Thyroid Uptaker Ratio Assay | K791172 | FDA 510(k) | N/A | Active |
| Beta Ffirm Test | K823682 | FDA 510(k) | Class II | Active |
| Oreia Ii B-Hcg, Enzyme Innunoassay | K832801 | FDA 510(k) | Class II | Active |
| Hypronosticon Tm | K770603 | FDA 510(k) | Class I | Active |
| Sterigage Eo Ethyl. Oxide Steril. Indic. | K802634 | FDA 510(k) | Class II | Active |
| Oreia - Digoxin | K790521 | FDA 510(k) | Class II | Active |
| Accurate I | K812261 | FDA 510(k) | Class II | Active |
| Thermometer, Single Use, Strip, Tempadot | K771038 | FDA 510(k) | Class I | Active |
| Duoclon Color-Cept | K842314 | FDA 510(k) | Class II | Active |
| Liquaemin Sodium, Heparin Sodium Etc. | K771305 | FDA 510(k) | Class II | Active |
| JADA System | JADA-2002 | EUDAMEDFDA UDI | Class IIa | Active |
| Gonosticon Dri-Dot Test | K771397 | FDA PMA | Class I | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.