FDA Registration
Active
🇺🇸 United States
CLINICAL REFERENCE LABORATORY, INC.
Reg #: 1910144
·
FEI: 1910144
·
Expires 2026
Products
20
Proprietary Names
3
Establishment Types
2
Classifications
20
Registration Details
- Registration Name
- CLINICAL REFERENCE LABORATORY, INC.
- Registration Number
- 1910144
- FEI Number
- 1910144
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8433 Quivira Rd
- City
- Lenexa
- State
- KS
- ZIP
- 66215
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210327
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 |
|---|---|---|---|---|---|
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2011-09-09 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-12-15 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| 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, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2022-06-09 |
| Enzyme Immunoassay, Benzodiazepine | JXM | 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, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2022-06-09 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2022-06-09 |
Proprietary Names
CRL Collection Kit
CRL Stat
CRL-Stat
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198