FDA Registration Active 🇺🇸 United States

ZEPTOMETRIX LLC.

Reg #: 3012101172 · FEI: 1318994 · Expires 2026
Products
3
Proprietary Names
48
Establishment Types
2
Classifications
3

Registration Details

Registration Name
ZEPTOMETRIX LLC.
Registration Number
3012101172
FEI Number
1318994
Status
Active
Expiry Year
2026
Initial Importer
No
Address
878 Main Street
City
Buffalo
State
NY
ZIP
14202
Country
US

Owner / Operator

Firm Name
Zeptometrix
Operator Number
10050261
Address
878 Main Street
City
Buffalo
State
NY
Postal Code
14202
Country
US

Products

Device Name Product Code
Multi-Analyte Controls Unassayed OHQ
Clinical Sample Concentrator JJH
Preservative, Cytological LEA

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 Sample Transport Reagent

Establishment Types

Manufacture Medical Device Manufacture Device in the United States for Export Only