FDA Registration
Active
🇺🇸 United States
LABONE, INC.
Reg #: 1930987
·
FEI: 1930987
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- LABONE, INC.
- Registration Number
- 1930987
- FEI Number
- 1930987
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10101 Renner Blvd
- City
- LENEXA
- State
- KS
- ZIP
- 66219
- Country
- US
Owner / Operator
- Firm Name
- LABONE, LLC., d/b/a Quest Diagnostics
- Operator Number
- 9004417
- Address
- 10101 RENNER BLVD., --
- City
- Lenexa
- State
- KS
- Postal Code
- 66219
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2020-08-19 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | Class 2 | Clinical Toxicology | No | 2018-03-05 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2019-09-03 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2001-11-06 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2019-04-17 |
| Covid-19 Test Home Collection Kit Devices | QLW | Class N | Unknown | No | 2021-12-20 |
Proprietary Names
Convenience Kit for Collecting and Transporting Upper Respiratory Specimens
HairCheck-DT (THC)
Delayed Semen Analysis Media
US Urine Examiner Kit
US Paramed Collection Oral Fluid Kit
US Blood And Urine Kit
QCard WHS
Quest Diagnostics Collection Kit for COVID-19 (Individual & Activate)
Quest Diagnostics Collection Kit for COVID-19 (Bulk)
Quest Diagnostics Collection Kit for COVID-19 (Bulk & Activate)
Quest Diagnostics Collection Kit for COVID-19 (Individual)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device