Contract manufacturerSTANBIO LABORATORY (Boerne, TX)TexasClinical toxicologyMicrobiologyClass II
STANBIO LABORATORY
Contract manufacturer · Boerne, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1616487 (openFDA record; or search FDA's registration database)
- FEI number
- 1616487
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- STANBIO LABORATORY (FDA owner/operator no. 1616487)
- Registered address
- 1261 NORTH MAIN ST., Boerne, TX 78006
- 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 |