MedtechSourcebook

AZER SCIENTIFIC, INC.

Contract manufacturer · Morgantown, PA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3009963993 (openFDA record; or search FDA's registration database)
FEI number
3009963993
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
Azer Scientific, LLC (FDA owner/operator no. 9062234)
Registered address
701 Hemlock Rd, Morgantown, PA 19543
Contract listings
19 device listings, 19 product codes, first listed Jun 19, 2006
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
GGHIron StainsClass IHematologyContract manufacturingFeb 21, 2025
GIFDiluent, Blood CellClass IHematologyContract manufacturingAug 13, 2010
HYBEosin YClass IHematologyContract manufacturingFeb 21, 2025
HYCFast GreenClass IHematologyContract manufacturingFeb 21, 2025
HYFGiemsa StainClass IHematologyContract manufacturingFeb 21, 2025
HYJHematoxylinClass IHematologyContract manufacturingFeb 21, 2025
HYKHematoxylin Harris'SClass IHematologyContract manufacturingFeb 21, 2025
HZHOrange GClass IHematologyContract manufacturingFeb 21, 2025
HZTReagent, SchiffClass IHematologyContract manufacturingFeb 21, 2025
IDAAlcian BlueClass IHematologyContract manufacturingFeb 21, 2025
IFPFormalin, Neutral BufferedClass IPathologyContract manufacturingDec 13, 2012
KDXSolution, Decalcifier, Acid ContainingClass IPathologyContract manufacturingFeb 21, 2025
KEQMedia, Mounting, Water SolubleClass IPathologyContract manufacturingFeb 21, 2025
KQCStains, HematologyClass IHematologyContract manufacturingFeb 21, 2025
LDYFixative, Formalin-ContainingClass IPathologyContract manufacturingDec 13, 2012
LEBMounting MediaClass IPathologyContract manufacturingFeb 21, 2025
NNIContainer, Specimen, Non-SterileClass IPathologyContract manufacturingJun 19, 2006
PPMGeneral Purpose ReagentClass IPathologyContract manufacturingJan 14, 2026
QKPCoronavirus Antigen Detection Test System.Not classifiedMicrobiologyContract manufacturingJun 11, 2021