Data / Medical devices / United States / Baebies Inc.

Baebies Inc.: FDA-registered device maker in Durham, NC, United States, 3 510(k) clearances

Name: Baebies Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Baebies Inc. is registered with the FDA (registration 3011240982) in Durham, NC, United States. It lists 11 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 11, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011240982
Address: 25 Alexandria Way, Durham, NC, United States, 27703
Owner or operator: BAE-B01 (10049734)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export
First device listed: July 20, 2015
Registered through: 2026
Brand names listed: ANALYTE SPECIFIC REAGENT, FINDER Flu A&B/SARS-CoV-2, FINDER G6PD Test System, Baebies, Finder, GENERAL PURPOSE REAGENT, SEEKER

Devices it lists

Device	Product code	Class	Role	Source
Alpha-D-Galactosidase A (Gla) Newborn Screening Test System	PQW	2	Contract manufacturer	accessdata.fda.gov
Alpha-D-Glucosidase (Gaa) Newborn Screening Test System	PQU	2	Contract manufacturer	accessdata.fda.gov
Alpha-L-Iduronidase (Idua) Newborn Screening Test System	PQT	2	Contract manufacturer	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Manufacturer for export	accessdata.fda.gov
General Purpose Reagent	PPM	1	Contract manufacturer	accessdata.fda.gov
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative	JBL	2	Manufacturer for export	accessdata.fda.gov
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening	JBF	2	Manufacturer	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Contract manufacturer	accessdata.fda.gov
Station, Pipetting And Diluting, For Clinical Use	JQW	1	Manufacturer for export	accessdata.fda.gov
ß-Glucocerebrosidase (Gba) Newborn Screening Test System	PQV	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 11, 2026	K261837	FINDER Flu A&B/SARS-CoV-2 Test	QOF	Substantially Equivalent	Baebies, Inc.	accessdata.fda.gov
March 30, 2026	K252269	FINDER Flu A&B/SARS-CoV-2 Test	QOF	Substantially Equivalent	Baebies, Inc.	accessdata.fda.gov
September 14, 2022	K201049	FINDER G6PD	JBF	Substantially Equivalent	Baebies, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.