Contract manufacturerRegenlab USA LLC (Jersey City, NJ)New JerseyHematologyClass I
Regenlab USA LLC
Contract manufacturer ยท Jersey City, NJ
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010512490 (openFDA record; or search FDA's registration database)
- FEI number
- 3010512490
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- RegenLab (FDA owner/operator no. 10033110)
- Registered address
- 95 Greene St, Jersey City, NJ 07302
- Contract listings
- 2 device listings, 2 product codes, first listed Jun 30, 2015
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | Class I | Hematology | Contract manufacturing | Jun 23, 2021 |
| KJC | Bottle, Roller, Tissue Culture | Class I | Hematology | Contract manufacturing | Jun 30, 2015 |