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Sign in to claim this brandBAEBIES INC.
US
Last updated September 17, 2026
What BAEBIES INC. makes
Baebies Inc. manufactures in vitro diagnostics (IVDs) for newborn metabolic screening and congenital disorder testing, including reagents, controls, calibrators, and enzyme fluorescence kits for detecting conditions like glucose-6-phosphate dehydrogenase (G6PD) deficiency. The company also produces laboratory and point-of-care multichannel clinical chemistry analysers, as well as mechanical pipettes and dilution sets for sample preparation.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- 25 Alexandria Way, Durham, NC, 27703
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3011240982
- DUNS Number
- —
Catalogue (40)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Baebies | 0976 | FDA UDI | Class I | Active |
| Seeker™ | 1201 | FDA UDI | Class II | Active |
| Seeker™ | 3145 | FDA UDI | Class I | Unknown |
| Seeker™ | 1305 | FDA UDI | Class I | Active |
| Finder | 800-000087 | FDA UDI | Class I | Active |
| Seeker™ | 1204 | FDA UDI | Class I | Active |
| Seeker™ | 1203 | FDA UDI | Class II | Active |
| Baebies 6-HMU Dilution Set | 2110 | FDA UDI | Class I | Active |
| Seeker™ | 2129 | FDA UDI | Class II | Active |
| Seeker™ | 3416 | FDA UDI | Class I | Active |
| Baebies C-Stop Solution | 3673 | FDA UDI | Class I | Active |
| Seeker™ | 2128 | FDA UDI | Class II | Active |
| Seeker™ | 2115 | FDA UDI | Class II | Active |
| Seeker™ | 3132 | FDA UDI | Class I | Unknown |
| Baebies | 0977 | FDA UDI | Class I | Active |
| Finder | 3409 | FDA UDI | Class II | Active |
| Finder | 110-000014 | FDA UDI | Class II | Active |
| Seeker™ | 0305 | FDA UDI | Class I | Active |
| Seeker™ | 3154 | FDA UDI | Class I | Active |
| Baebies 4-MU IDS | 3640 | FDA UDI | Class I | Active |
| Baebies | 3369 | FDA UDI | Class I | Active |
| Seeker™ | 1202 | FDA UDI | Class II | Active |
| Seeker™ | 1200 | FDA UDI | Class II | Active |
| Finder | 100-000009 | FDA UDI | Class II | Active |
| Seeker™ | 0802 | FDA UDI | Class I | Active |
| Seeker™ | 2111 | FDA UDI | Class II | Active |
| Baebies Stop Solution | 2105 | FDA UDI | Class I | Active |
| Baebies | 0974 | FDA UDI | Class I | Active |
| Seeker™ | 2188 | FDA UDI | Class I | Active |
| Baebies 6-HMU GALC | 2103 | FDA UDI | Class I | Active |
| Seeker™ | 2130 | FDA UDI | Class II | Active |
| Baebies Extraction Solution | 2114 | FDA UDI | Class I | Active |
| Finder | 100-000020 | FDA UDI | Class I | Active |
| Baebies 4-MU Dilution Set | 3952 | FDA UDI | Class I | Active |
| Baebies | 0975 | FDA UDI | Class I | Active |
| Seeker™ | 3428 | FDA UDI | Class I | Active |
| Seeker™ | 2131 | FDA UDI | Class II | Active |
| SEEKER System | DEN150035 | FDA 510(k) | Class II | Active |
| Finder G6pd | K201049 | FDA 510(k) | Class II | Active |
| FINDER Flu A&B/SARS-CoV-2 Test | K252269 | FDA 510(k) | Class II | Active |
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