Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000202849

FEI Number

3000202849

Entity Name

ZEPTOMETRIX LLC

City/State/Country

Franklin, MA, US

Establishment Address

25 Kenwood Circle, Franklin, MA 02038, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zeptometrix (Owner Number: 10050261)

Owner / Operator Contact Address

878 Main Street, Buffalo, NY 14202, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NATtrol Respiratory Bundle NATtrol GI Controls NATtrol Respiratory/Sore Throat (R/ST) Control Kit NATtrol C. difficile Negative Control NATtrol Vaginal Bundle NATtrol MRSA/SA Negative Control NATtrol Chlamydia trachomatis (CT) Positive Control NATtrol Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control NATtrol Influenza A/B Positive Control NATtrol GBS Negative Control NATtrol SARS-Related Coronavirus 2 Negative Control (1 mL NATtrol Flu/RSV/SARS-CoV-2 Positive Control NATtrol GBS Positive Control NATtrol SARS-Related Coronavirus 2 Negative Control (0.5 mL) NATtrol Norovirus Negative Control NATtrol CT/NG/TV Positive Control NATtrol Mpox Virus Negative Control NATtrol Influenza/RSV Negative Control NATtrol SA Positive Control NATtrol Neisseria gonorrhoeae (NG) Positive Control NATtrol Trichomonas vaginalis Negative Control NATtrol MRSA Positive Control NATtrol Trichomonas vaginalis Positive Control NATtrol Hepatitis C Virus Positive Control NATtrol Flu/RSV/SARS-CoV-2 Negative Control NATtrol CT Positive Control Pack NATtrol Norovirus GI/GII Positive Control NATtrol CT/NG/TV Negative Control NATtrol RSV Positive Control NATtrol Flu/RSV/SARS-CoV-2 Negative Control Swabs NATtrol SARS-Related Coronavirus 2 Positive Control (1 mL) NATtrol NG Positive Control Pack NATtrol Vaginal Positive Control NATtrol C. difficile Positive Control NATtrol Strep A Positive Control NATtrol Flu/RSV/SARS-CoV-2 Positive Control Swabs NATtrol CT/NG Negative Control Pack NATtrol Vaginal Negative Control NATtrol Mpox Virus Positive Control NATtrol Hepatitis C Virus Negative Control NATtrol Meningitis/Encephalitis (ME) Controls NATtrol Strep A Negative Control NATtrol SARS-Related Coronavirus 2 Positive Control (0.5 mL) NATtrol Vaginal Mini Bundle NATtrol Respiratory Positive Control NATtrol Respiratory Negative Control NATtrol Flu/RSV/SARS-CoV-2 Swab Control Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2019-04-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zeptometrix

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012101172	ZEPTOMETRIX LLC.	Buffalo, NY, US

Similar Registrations

Registration Number	Establishment Name	Location
8043909	WALLAC OY	TURKU Varsinais-Suomi, FI
2432495	BIOCHEMICAL DIAGNOSTICS, INC.	Edgewood, NY, US
3008156187	TECHNO-PATH MANUFACTURING LTD.	Ballina Tipperary, IE
2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US
3021090658	Ortho-Clinical Diagnostics, Inc.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000202849. Last updated year: 2026. Please use registration number 3000202849 when referencing this establishment in official correspondence.