FDA Registration Active 🇺🇸 United States

NATtrol™ CT/NG/TV External Run Control Kit

Reg #: 3012101172 · FEI: 1318994 · Expires 2025
Products
1
Proprietary Names
39
Establishment Types
1
Classifications
1

Registration Details

Registration Name
ZEPTOMETRIX LLC.
Registration Number
3012101172
FEI Number
1318994
Status
Active
Expiry Year
2025
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
Correspondent
Diane Waterman

Products

Device Name Product Code
Multi-Analyte Controls Unassayed OHQ

Proprietary Names

NATtrol™ CT/NG/TV External Run Control Kit NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control Swabs NATtrol™ SARS-Related Coronavirus 2 Negative Control (0.5 mL) NATtrol™ Influenza/RSV Negative Control NATtrol™ RSV Positive Control NATtrol™ Neisseria gonorrhoeae (NG) Positive Control NATtrol™ MRSA/SA Negative Control NATtrol™ Mpox Virus Positive Control NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control NATtrol™ CT Positive Control Pack NATtrol™ Chlamydia trachomatis (CT) Positive Control NATtrol™ MRSA Positive Control NATtrol™ Hepatitis C Virus Negative Control NATtrol™ Mpox Virus Negative Control NATtrol™ C. difficile Negative Control NATtrol Vaginal Bundle NATtrol™ Influenza A/B Positive Control NATtrol™ C. difficile Positive Control NATtrol™ Vaginal Mini Bundle NATtrol™ GBS Negative Control NATtrol™ SARS-Related Coronavirus 2 Negative Control (1 mL NATtrol™ SA Positive Control NATtrol™ Norovirus GI/GII Positive Control NATtrol™ CT/NG/TV Negative Control NATtrol™ Hepatitis C Virus Positive Control NATtrol™ GBS Positive Control NATtrol™ SARS-Related Coronavirus 2 Positive Control (1 mL) NATtrol™ Norovirus Negative Control NATtrol™ CT/NG/TV Positive Control NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control NATtrol™ NG Positive Control Pack NATtrol Vaginal Positive Control NATtrol™ SARS-Related Coronavirus 2 Positive Control (0.5 mL) NATtrol™ Trichomonas vaginalis Negative Control NATtrol™ CT/NG Negative Control Pack NATtrol Vaginal Negative Control NATtrol™ Trichomonas vaginalis Positive Control NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control Swabs

Establishment Types

Manufacture Medical Device