Contract manufacturerBAEBIES INC. (Durham, NC)North CarolinaPathologyClinical chemistryClass IClass II
BAEBIES INC.
Contract manufacturer · Durham, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3011240982 (openFDA record; or search FDA's registration database)
- FEI number
- 3011240982
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- BAE-B01 (FDA owner/operator no. 10049734)
- Registered address
- 25 Alexandria Way, Durham, NC 27703
- Contract listings
- 3 device listings, 6 product codes, first listed Jul 20, 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 |
|---|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Class I | Pathology | Contract manufacturing | Jul 20, 2015 |
| PPM | General Purpose Reagent | Class I | Pathology | Contract manufacturing | Dec 30, 2016 |
| PQT | Alpha-L-Iduronidase (Idua) Newborn Screening Test System | Class II | Clinical chemistry | Contract manufacturing | May 10, 2017 |
| PQU | Alpha-D-Glucosidase (Gaa) Newborn Screening Test System | Class II | Clinical chemistry | Contract manufacturing | May 10, 2017 |
| PQV | ß-Glucocerebrosidase (Gba) Newborn Screening Test System | Class II | Clinical chemistry | Contract manufacturing | May 10, 2017 |
| PQW | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | Class II | Clinical chemistry | Contract manufacturing | May 10, 2017 |