Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011240982

FEI Number

3011240982

Entity Name

BAEBIES INC.

City/State/Country

Durham, NC, US

Establishment Address

25 Alexandria Way, Durham, NC 27703, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BAE-B01 (Owner Number: 10049734)

Owner / Operator Contact Address

25 Alexandria Way Durham, NC 27703 USA, Durham, NC 27703, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252269

PMA Number

N/A

All Registered Proprietary Names

FINDER G6PD Test System, Baebies, Finder GENERAL PURPOSE REAGENT ANALYTE SPECIFIC REAGENT FINDER Flu A&B/SARS-CoV-2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JBF	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening	Hematology	Class 2	864.7360	2022-12-08
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2016-12-30
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2019-12-30
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2015-07-20
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2026-04-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BAE-B01

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

Similar Registrations

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9681576	TRINITY BIOTECH, PLC	BRAY Wicklow, IE
3011661720	TRUCKEE APPLIED GENOMICS INC	Reno, NV, US
3005504113	KEMENTEC SOLUTIONS AS	Taastrup Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011240982. Last updated year: 2026. Please use registration number 3011240982 when referencing this establishment in official correspondence.