QIAGEN

FDA Device Registration & Listing · Germantown, MD, US · Registration 1122376

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1122376
FEI Number
3003572099
Entity Name
QIAGEN
City/State/Country
Germantown, MD, US
Establishment Address
19300 Germantown Rd, Germantown, MD 20874, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
QIAGEN Sciences LLC (Owner Number: 9002668)
Owner / Operator Contact Address
19300 Germantown Road, --, Germantown, MD 20874, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 digene® HC2 CT/GC 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LSK Dna-Reagents, Chlamydia Microbiology Class 1 866.3120 2008-05-02
MAQ Kit, Dna Detection, Human Papillomavirus Unknown Class 3 N/A 2013-09-12
HHT Spatula, Cervical, Cytological Obstetrics/Gynecology Class 2 884.4530 2008-05-02
PPM General Purpose Reagent Pathology Class 1 864.4010 2009-10-09
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2003-04-16
NQM Immunoassay For Detection Of Amniotic Fluid Protein(S). Clinical Chemistry Class 1 862.1550 2015-08-18
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2001-10-25
LSL Dna-Reagents, Neisseria Microbiology Class 2 866.3390 2008-05-02
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-11-28
NQM Immunoassay For Detection Of Amniotic Fluid Protein(S). Clinical Chemistry Class 1 862.1550 2016-11-30
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-11-30
NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown Class 3 N/A 2015-05-28
QBB Placental Alpha Microglobulin-1 Immunoassay Unknown Class 3 N/A 2018-05-23
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2006-10-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

QIAGEN Sciences LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K963801 Young OU Brush Co. PAP BRUSH 1997-04-09
K851403 Ventrex Laboratories, Inc. VENTREZYME ALLERGEN DATA REDUCTION SYSTEM 1985-06-21
K761290 Nuclear Medical Laboratories, Inc. COMPU-PET 300 1977-02-24
K770210 G.D. Searle and Co. ANALYTIX AUTO SAMPLE PREP. STA. 1600 1977-02-14
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2013 Beckman Coulter Inc. 1
COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012 Beckman Coulter Inc. 1
Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1122376. Last updated year: 2026. Please use registration number 1122376 when referencing this establishment in official correspondence.
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