FDA Registration
Active
🇺🇸 United States
CEDIA THC Calibrators
Reg #: 3010939897
·
FEI: 3010939897
·
Expires 2025
Products
1
Proprietary Names
51
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Microgenics Corporation
- Registration Number
- 3010939897
- FEI Number
- 3010939897
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 46500 Kato Road
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2018-09-07 |
Proprietary Names
CEDIA THC Calibrators
QMS Gentamicin Calibrators
DRI Methadone Metabolite 300ng/mL Calibrator
CEDIA PPX/Methadone Intermediate Calibrator
QMS Lamotrigine Calibrator
DRI Hydrocodone Assay Calibrator 1000
CEDIA PPX/Methadone High Calibrator
DRI Oxycodone Calibrator 0
CEDIA Methamphetamine OFT Negative Calibrator
QMS Vancomycin Calibrators
DRI Oxycodone Calibrator 100
CEDIA Mycophenolic Acid Calibrators
Multigent Quinidine Calibrators
DRI Methadone Metabolite 2000ng/mL Calibrator
Alinity c Cannabinoids Semiquant 200 Calibrator Kit
DRI Opiate Urine Calibrators
Alinity c Tobramycin Calibrators
DRI Hydrocodone Assay Calibrator 500
CEDIA Methamphetamine OFT Cut off Calibrator
Alinity c Opiates Semiquant Calibrator Kit
DRI Ecstasy Calibrators
CEDIA Buprenorphine Calibrators
Alinity c Opiates Qual Calibrator Kit
QMS Zonisamide Calibrator
DRI THC Urine Calibrators
QMS Tobramycin Calibrators
CEDIA LSD Calibrators
CEDIA Heroin Metabolite (6-AM) Cutoff Calibrator
DRI Hydrocodone Assay Calibrator 100
CEDIA Heroin Metabolite (6-AM) High Calibrator
DRI Oxycodone Calibrator 1000
DRI Methadone Metabolite 150ng/mL Calibrator
CEDIA Buprenorphine II Calibrators
QMS Amikacin Calibrator
QMS Plazomicin Immunoassay Calibrator
CEDIA THC OFT Negative Calibrator
QMS Lidocaine Calibrators
CEDIA PPX/Methadone Cutoff Calibrator
DRI Oxycodone Calibrator 500
CEDIA THC OFT Cutoff Calibrator
DRI Oxycodone Calibrator 300
QMS Everolimus Calibrator
DRI Methadone Metabolite 1000ng/mL Calibrator
QMS Quinidine Calibrator Set
Alinity c Ecstasy Qual Calibrator Kit
DRI Hydrocodone Assay Calibrator 300
Alinity c Cannabinoids Qual Calibrator Kit
Alinity c Ecstasy Semiquant Calibrator Kit
Alinity c Cannabinoids Semiquant 100 Calibrator Kit
Siemens Atellica MetMtb Cal
Siemens ADVIA Chemistry Methadone Metabolite Urine Calibrators
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device