Contract manufacturerEKF Life Sciences (South Bend, IN)IndianaClinical toxicologyMicrobiologyClass II
EKF Life Sciences
Contract manufacturer ยท South Bend, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3017101757 (openFDA record; or search FDA's registration database)
- FEI number
- 3017101757
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- STANBIO LABORATORY (FDA owner/operator no. 1616487)
- Registered address
- 6879 Enterprise Drive, Suite 500, South Bend, IN 46628
- Contract listings
- 5 device listings, 3 product codes, first listed Dec 30, 2011
- 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 |
|---|---|---|---|---|---|
| DKJ | Colorimetry, Salicylate | Class II | Clinical toxicology | Contract manufacturing | Dec 30, 2011 |
| LDP | Colorimetry, Acetaminophen | Class II | Clinical toxicology | Contract manufacturing | Dec 30, 2011 |
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | Class II | Microbiology | Contract manufacturing | Apr 29, 2020 |