FDA Registration
Active
🇺🇸 United States
CRL-Stat
Reg #: 1910144
·
FEI: 1910144
·
Expires 2025
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- CLINICAL REFERENCE LABORATORY, INC.
- Registration Number
- 1910144
- FEI Number
- 1910144
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8433 Quivira Rd
- City
- Lenexa
- State
- KS
- ZIP
- 66215
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153597
Owner / Operator
- Firm Name
- Clinical Reference Laboratory
- Operator Number
- 10038059
- Address
- 8433 Quivira Rd
- City
- Lenexa
- State
- KS
- Postal Code
- 66215
- Country
- US
- Correspondent
- Rebecca Henkhaus
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-06-09 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2022-06-09 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2022-06-09 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2022-06-09 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2022-06-09 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2022-06-09 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2022-06-09 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2022-06-09 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2022-06-09 |
Proprietary Names
CRL-Stat
Establishment Types
Repack or Relabel Medical Device