FDA Registration
Active
🇺🇸 United States
Drucker Diagnostics, LLC
Reg #: 3011765035
·
FEI: 3011765035
·
Expires 2026
Products
3
Proprietary Names
82
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- Drucker Diagnostics, LLC
- Registration Number
- 3011765035
- FEI Number
- 3011765035
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 200 Shady Ln Ste 170
- City
- Philipsburg
- State
- PA
- ZIP
- 16866
- Country
- US
Regulatory Submissions
- 510(k) Number
- K891276
Owner / Operator
- Firm Name
- DRUCKER DIAGNOSTICS
- Operator Number
- 9078843
- Address
- 200 Shady Lane, Suite 170
- City
- Philipsburg
- State
- PA
- Postal Code
- 16866
- Country
- US
- Correspondent
- Stephen Naspinski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2007-10-16 |
| Tube, Collection, Capillary Blood | GIO | Class 1 | Hematology | No | 2014-10-23 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2013-12-23 |
Proprietary Names
QBC PARAVIEWER
QBC MALARIA TEST
QBC MALARIA SYSTEM
QBC PARALENS ADVANCE
QBC STAR BLOOD COLLECTION TUBE
REFURB, QBC STAR CENTRIFUGAL DRY HEMATOLOGY SYSTEM
QBC STAR CENTRIFUGAL DRY HEMATOLOGY SYSTEM
Capillary Sample Transfer Tube
Venous Tube, Blood Collection Device
Capillary Tube, Blood Collection Device
Heparin/EDTA Coated Tube
QBC CENTRIFUGE
REFURB, QBC AUTOREAD
QBC AUTOREAD PLUS
QBC ACCUTUBE
REFURB, QBC CENTRIFUGE
REFURB, QBC AUTOREAD PLUS
QBC AUTOREAD
TRUEBOND CENTRIFUGE
TRUEBOND SET 3 CENTRIFUGE
HORIZON 6 MAX (DC) CENTRIFUGE
TRUEBOND DUET CENTRIFUGE
DASH APEX 12 CENTRIFUGE
842E CENTRIFUGE
755 CENTRIFUGE
BOOST 2+ CENTRIFUGE
HORIZON 24 CENTRIFUGE
HORIZON 12 FLEX CENTRIFUGE
842HS CENTRIFUGE
DASH COAG CENTRIFUGE
642E CENTRIFUGE
BOOST 2 FLEX CENTRIFUGE
SERO 12 CENTRIFUGE
HORIZON 24 FLEX CENTRIFUGE
755-12 CENTRIFUGE
642VFD CENTRIFUGE
755-24 CENTRIFUGE
614VET CENTRIFUGE
755V-12 CENTRIFUGE
756 CENTRIFUGE
HORIZON 6FA CENTRIFUGE
BOOST 4+ FLEX CENTRIFUGE
653V CENTRIFUGE
DASH FLEX 12 CENTRIFUGE
DASH MICRO CENTRIFUGE
HORIZON 6 FLEX FA CENTRIFUGE
BOOST 2 CENTRIFUGE
642B CENTRIFUGE
BOOST 2+ FLEX CENTRIFUGE
DASH APEX 4 CENTRIFUGE
DASH APEX 6 CENTRIFUGE
853VES CENTRIFUGE
755V-24 CENTRIFUGE
DASH APEX 24 CENTRIFUGE
614M CENTRIFUGE
614B CENTRIFUGE
642VFD PLUS CENTRIFUGE
755V CENTRIFUGE
642VES CENTRIFUGE
755VES-230V CENTRIFUGE
HORIZON 6 FLEX CENTRIFUGE
DASH FLEX 24 CENTRIFUGE
653ES CENTRIFUGE
642M CENTRIFUGE
755VES CENTRIFUGE
HORIZON 6 CENTRIFUGE
842VES CENTRIFUGE
BOOST 2+ MAX CENTRIFUGE
TRUEBOND TRIFLEX CENTRIFUGE
842 STAT CENTRIFUGE
HORIZON 12 CENTRIFUGE
653E CENTRIFUGE
HORIZON 6FA (DC) CENTRIFUGE
BOOST PRO CENTRIFUGE
614L CENTRIFUGE
HORIZON 6 (DC) CENTRIFUGE
DASH FLEX 6 CENTRIFUGE
HORIZON 6 FLEX FA (DC) CENTRIFUGE
HORIZON 6 FLEX (DC) CENTRIFUGE
DASH PRO 24 CENTRIFUGE
BOOST 4 CENTRIFUGE
HORIZON 6 MAX CENTRIFUGE
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Remanufacture Medical Device