FDA Registration
Active
🇺🇸 United States
ZEPTOMETRIX LLC
Reg #: 3000202849
·
FEI: 3000202849
·
Expires 2026
Products
1
Proprietary Names
47
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ZEPTOMETRIX LLC
- Registration Number
- 3000202849
- FEI Number
- 3000202849
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 25 Kenwood Circle
- City
- Franklin
- State
- MA
- ZIP
- 02038
- 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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2019-04-25 |
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
Establishment Types
Manufacture Medical Device