Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009963993

FEI Number

3009963993

Entity Name

AZER SCIENTIFIC, INC.

City/State/Country

Morgantown, PA, US

Establishment Address

701 Hemlock Rd, Morgantown, PA 19543, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Azer Scientific, LLC (Owner Number: 9062234)

Owner / Operator Contact Address

701 Hemlock Road, --, Morgantown, PA 19543, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Giemsa Stain Azer Scientific Universal Transport Medium (UTM) - PFUTM-10 High Profile Microtome Blades Trimming Blades Low Profile Microtome Blades Deionized water; reagent grade water; high purity water Biohazard transport bag AzerPath Embedding Center, AzerPath Embedding Center Hot Module Buffered Blood Bank Saline Blood Bank Saline with preservative Blood Bank Saline Non-Buffered Blood Bank Saline AzerPath Embedding Center, AzerPath Embedding Center Cold Plate Module Gram Decolorizer AFB Methylene Blue Crystal Violet Solution AFB Carbol Fuchsin AFB Kinyoun Reagent, Schiff 37% Formaldehyde 10% NBF AUTOPLAK Automated Plate Streaker GENERAL PURPOSE, LABELED OR PROMOTED FOR; SPECIMEN COLLECTION HOLDER Azer Tissue Marking Dye AzerPath Tissue Marking Dye Azer Mesh Cassette Azer Biopsy Cassette Azer Tissue Cassette SAF-FIXATIVE Fully Automatic IHC Stainer CNT320; Fully Automatic IHC Staining System CNT360-M1; Fully Automatic Immunohistochemistry NG-TEST® CARBA 5, for Detection of Five Bacterial Carbapenemase Enzyme TrueForm Vertex X6 Azer Nitrile Ultra Gloves Azer Gloves Standard Nitrile Azer Nitrile Plus Gloves Azer Nitrile Ultra Aloe Gloves TrueForm Everyday Nitrile TrueForm Extra Thin Nitrile Hematoxylin Clean Catch Kit Face Mask; Surgical Mask; Azer Surgical Mask; Azer Surgical Mask with Eye Shield; Azer Tie-Back Surgical Mask Solution, Decalcifier, Acid Containing Elite Acid Rinse 1 Hematoxylin Harris's Nasopharyngeal swab, Individually wrapped, sterile (ES45010) Specimen collection swab, individually wrapped, sterile (ES45013) Foam Swab, individually wrapped, sterile (ES45019S) Wright's Stain Fixative Mounting Media Drugs of abuse 12 in 1 test cup First Sign for Hemosure Formagel NG-TEST® CTX-M Multi, for Rapid ESBL Organism Detection Tube Vacutainer Azer Infant Heel Warmer Everclear Xylene Substitute D-Limonene Eosin Y Plasma Freezer Blood Bank Refrigerator Azer Cover Glass Media, Mounting, Water Soluble Fast Green Gram Stain Reagent, Safranin Papanicolaou Stain Easy Pap Stain Papanicolaou Stain Og-6 Spinplus Centrifuge Foam Swab, Bulk, Non-Sterile (ES45019) EVERMARK SELECT HISTOBOND UNIMARK AZERMARK EVERFROST EVERMARK UNIFROST Pipet tip for automation Acid-fast stain kit; ACTH (Polyclonal), RPab; Actin, Muscle Specific Actin (C8E11), MMab; Alcian Blue stain kit; ALK (5A Azer Scientific Universal Transport Medium (UTM) - PFUTM-10 Alcian blue

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HYF	Giemsa Stain	Hematology	Class 1	864.1850	2025-02-21
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2020-09-04
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2022-05-09
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2026-01-14
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2026-04-06
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2013-09-10
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2010-08-13
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2024-04-19
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2024-06-27
HZT	Reagent, Schiff	Hematology	Class 1	864.1850	2025-02-21
IGG	Formaldehyde (Formalin, Formol)	Pathology	Class 1	864.4010	2012-12-13
IFP	Formalin, Neutral Buffered	Pathology	Class 1	864.4010	2012-12-13
JTC	Device, Microtiter Diluting/Dispensing	Microbiology	Class 1	866.2500	2026-01-14
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2022-09-27
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	2018-08-24
KER	Container, Embedding	Pathology	Class 1	864.3010	2012-10-31
IGB	Solution, Formalin-Sodium Acetate	Pathology	Class 1	864.4010	2025-03-26
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2026-01-14
PTJ	Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates	Microbiology	Class 2	866.1640	2026-04-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-04-03
HYJ	Hematoxylin	Hematology	Class 1	864.1850	2025-02-21
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2017-02-07
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2023-12-16
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-26
KDX	Solution, Decalcifier, Acid Containing	Pathology	Class 1	864.4010	2025-02-21
LED	Stains, Chemical Solution	Hematology	Class 1	864.1850	2016-10-07
HYK	Hematoxylin Harris'S	Hematology	Class 1	864.1850	2025-02-21
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-04-22
IAF	Wright'S Stain	Hematology	Class 1	864.1850	2026-04-06
LEB	Mounting Media	Pathology	Class 1	864.4010	2025-02-21
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2026-04-06
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2026-04-06
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2026-04-06
LDY	Fixative, Formalin-Containing	Pathology	Class 1	864.4010	2012-12-13
PTJ	Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates	Microbiology	Class 2	866.1640	2026-04-06
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2013-09-10
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-04-06
MPO	Infant Heel Warmer (Chemical Heat Pack)	Physical Medicine	Class 1	890.5710	2023-04-26
KEM	Agent, Clearing	Pathology	Class 1	864.4010	2016-01-26
HYB	Eosin Y	Hematology	Class 1	864.1850	2025-02-21
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	2026-04-06
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2018-08-24
KEQ	Media, Mounting, Water Soluble	Pathology	Class 1	864.4010	2025-02-21
HYC	Fast Green	Hematology	Class 1	864.1850	2025-02-21
HZS	Safranin	Hematology	Class 1	864.1850	2024-06-27
HZJ	Stain, Papanicolau	Hematology	Class 1	864.1850	2026-04-06
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2019-06-05
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-04-02
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2008-09-09
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2021-06-11
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2026-04-06
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2026-01-14
QMC	Transport Medium, Notified Per The Vtm Guidance	Microbiology	Class 1	866.2390	2021-03-02
IDA	Alcian Blue	Hematology	Class 1	864.1850	2025-02-21

Official Correspondent

Flip Britton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Azer Scientific, 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
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-05	Becton Dickinson & Co.	1	Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009963993. Last updated year: 2026. Please use registration number 3009963993 when referencing this establishment in official correspondence.