FDA Registration
Active
🇺🇸 United States
QIAGEN
Reg #: 1122376
·
FEI: 3003572099
·
Expires 2026
Products
12
Proprietary Names
19
Establishment Types
4
Classifications
12
Registration Details
- Registration Name
- QIAGEN
- Registration Number
- 1122376
- FEI Number
- 3003572099
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 19300 Germantown Rd
- City
- Germantown
- State
- MD
- ZIP
- 20874
- Country
- US
Regulatory Submissions
- 510(k) Number
- K990023
- PMA Number
- P010033
Owner / Operator
- Firm Name
- QIAGEN Sciences LLC
- Operator Number
- 9002668
- Address
- 19300 Germantown Road, --
- City
- Germantown
- State
- MD
- Postal Code
- 20874
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dna-Reagents, Chlamydia | LSK | Class 1 | Microbiology | No | 2008-05-02 |
| Kit, Dna Detection, Human Papillomavirus | MAQ | Class 3 | Unknown | No | 2013-09-12 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2008-05-02 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2009-10-09 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2003-04-16 |
| Immunoassay For Detection Of Amniotic Fluid Protein(S). | NQM | Class 1 | Clinical Chemistry | No | 2015-08-18 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2001-10-25 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2008-05-02 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2023-11-28 |
| Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | NCD | Class 3 | Unknown | No | 2015-05-28 |
| Placental Alpha Microglobulin-1 Immunoassay | QBB | Class 3 | Unknown | No | 2018-05-23 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2006-10-31 |
Proprietary Names
digene® HC2 CT-ID DNA Test, Version 2
digene® HC2 CT/GC DNA Test, Version 2
digene® HPV Genotyping PS Test
digene® HC2 DNA Collection Device
Buffer AVL
digene® Female Swab Specimen Collection Kit
AmniSure® ROM (Rupture of [fetal] Membranes) Test
Rapid Capture® System (RCS)
digene® HC2 GC-ID DNA Test, Version 2
IGRA Control Set
AmniSure ROM Test Positive and Negative Controls Pack
QuantiFeron®-TB Gold Test
QuantiFeron®-TB Gold Plus Test
PartoSure Test
Lyophilized R848
Lyophilized Anti-CD3
digene® HC2 HPV DNA Test
digene® HC2 High-Risk HPV DNA Test
DML 3000
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility