FDA Registration
Active
🇺🇸 United States
Ameditech, Inc.
Reg #: 2032598
·
FEI: 3003789989
·
Expires 2026
Products
9
Proprietary Names
22
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- Ameditech, Inc.
- Registration Number
- 2032598
- FEI Number
- 3003789989
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9940 Mesa Rim Rd
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | Class 2 | Clinical Toxicology | No | 2020-03-03 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 1998-05-20 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | Class 2 | Clinical Toxicology | No | 2020-03-03 |
| Test, Methadone, Employment And Insurance Testing, Exempt | PVE | Class 2 | Clinical Toxicology | No | 2020-03-03 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | Class 2 | Clinical Toxicology | No | 2020-03-03 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | Class 2 | Clinical Toxicology | No | 2020-03-03 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | Class 2 | Clinical Toxicology | No | 2020-03-03 |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | Class 2 | Clinical Toxicology | No | 2020-03-03 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | Class 2 | Clinical Toxicology | No | 2020-03-03 |
Proprietary Names
eCUP + Drug Screening Device (REF 94615) - AMT Mfg
eReader+
SEFRIA Amphetamine Oral Fluid Enzyme Immunoassay 100mL Kit
eCUP + Drug Screening Device (REF 94615)
SEFRIA Amphetamine Oral Fluid Enzyme Immunoassay 500mL Kit
eCup+ Drug Screening Device (REF 94615)
SEFRIA Benzoylecgonine Oral Fluid 100 mL Kit
SEFRIA Benzoylecgonine Oral Fluid 500 mL Kit
eCUP + Drug Screening Device
Cannabinoid Oral Fluid HEIA 500 ml
Cannabinoid Oral Fluid HEIA 100 ml
SEFRIA Opiates Oral Fluid Enzyme Immunoassay 100 mL Kit
SEFRIA Hydrocodone Oral Fluid
SEFRIA Opiates Oral Fluid Enzyme Immunoassay 500 mL Kit
SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 500mL Kit
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay Kit 100 mL Kit
SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 100mL Kit
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay Kit 500 mL Kit
SEFRIA Ecstasy Oral Fluid Enzyme Immunoassay 100 mL kit
SEFRIA Ecstasy Oral Fluid Enzyme Immunoassay 500 mL kit
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay 100 mL Kit
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay 500 mL Kit
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device