Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013046485

FEI Number

3013046485

Entity Name

SIO2 MEDICAL PRODUCTS, LLC

City/State/Country

Auburn, AL, US

Establishment Address

2425 Innovation Dr, Auburn, AL 36832, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SiO2 Medical Products, LLC (Owner Number: 10075054)

Owner / Operator Contact Address

2425 innovation dr, Auburn, AL 36832, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PrimeStore MTM 1.5mL (82-9026-100-00) PrimeStore MTM 3mL (82-9033-100-00) PrimeStore MTM 2mL (82-9028-100-00)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2022-05-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SiO2 Medical Products, LLC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013046485. Last updated year: 2026. Please use registration number 3013046485 when referencing this establishment in official correspondence.