Data / Medical devices / United States / Azer Scientific, Inc.
Azer Scientific, Inc.: FDA-registered device maker in Morgantown, PA, United States, 9 510(k) clearances
Azer Scientific, Inc. is registered with the FDA (registration 3009963993) in Morgantown, PA, United States. It lists 63 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 4, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009963993
- Address
- 701 Hemlock Rd, Morgantown, PA, United States, 19543
- Owner or operator
- Azer Scientific, LLC (9062234)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 19, 2006
- Registered through
- 2026
- Brand names listed
- 10% NBF, 37% Formaldehyde, AFB Carbol Fuchsin, AFB Kinyoun, AFB Methylene Blue, AUTOPLAK Automated Plate Streaker, AZER CULTURE TUBE, AZERMARK and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Clearing | KEM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Alcian Blue | IDA | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Complaint file establishment | accessdata.fda.gov |
| Container, Embedding | KER | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Container, Sharps | MMK | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Sterile | KDT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Coronavirus Antigen Detection Test System. | QKP | N | Contract manufacturer | accessdata.fda.gov |
| Coverslips, Microscope Slide | KES | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Device, Accessory, Cooling Plate For Tissue Embedding Station | MXT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Device, Microtiter Diluting/Dispensing | JTC | 1 | Complaint file establishment | accessdata.fda.gov |
| Diluent, Blood Cell | GIF | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dispensers, Paraffin | IDW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Drink, Glucose Tolerance | MRV | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Enzyme Immunoassay, Amphetamine | DKZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | 2 | Complaint file establishment | accessdata.fda.gov |
| Eosin Y | HYB | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Complaint file establishment | accessdata.fda.gov |
| Fast Green | HYC | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Fixative, Formalin-Containing | LDY | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Formaldehyde (Formalin, Formol) | IGG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Formalin, Neutral Buffered | IFP | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Giemsa Stain | HYF | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Hematoxylin | HYJ | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Hematoxylin Harris'S | HYK | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Reagents And Kits | NJT | 1 | Complaint file establishment | accessdata.fda.gov |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | 1 | Complaint file establishment | accessdata.fda.gov |
| Iodine, Grams | HYI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Iron Stains | GGH | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Media, Mounting, Water Soluble | KEQ | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Microtome, Accessories | IDL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Microtome, Rotary | IDO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mounting Media | LEB | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orange G | HZH | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates | PTJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Reagent, Schiff | HZT | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Refrigerator, Freezer, Blood Storage | KSE | 2 | Complaint file establishment | accessdata.fda.gov |
| Safranin | HZS | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Slide Stainer, Automated | KPA | 1 | Complaint file establishment | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Solution, Decalcifier, Acid Containing | KDX | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Solution, Formalin-Sodium Acetate | IGB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stain, Papanicolau | HZJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stains, Chemical Solution | LED | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stains, Dye Solution | LEE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stains, Hematology | KQC | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Stains, Microbiologic | JTS | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | Complaint file establishment | accessdata.fda.gov |
| Transport Medium, Notified Per The Vtm Guidance | QMC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tube, Tissue Culture | KJG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Wright'S Stain | IAF | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 4, 2025 | K243499 | NG-Test® CTX-M MULTI | PTJ | Substantially Equivalent | Ng Biotech | accessdata.fda.gov |
| October 2, 2019 | K191889 | NG-Test CARBA 5 | PTJ | Substantially Equivalent | Ng Biotech | accessdata.fda.gov |
| October 7, 2014 | K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test | DIO | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| July 17, 2013 | K123787 | GREENCROSS SURGICAL MASK | FXX | Substantially Equivalent | Jingzhou Haixin Green Cross Medical Products Co.,L | accessdata.fda.gov |
| September 19, 2006 | K053254 | INFANT HEEL WARMER BY INTCO | MPO | Substantially Equivalent | Shanghai Intco Medical Supply Co., Ltd. | accessdata.fda.gov |
| October 27, 2004 | K042183 | GLUCOSE TOLERANCE BEVERAGE | MRV | Substantially Equivalent | Ever Scientific | accessdata.fda.gov |
| February 7, 2000 | K993876 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| November 6, 1998 | K983367 | QLICKSMART | MMK | Substantially Equivalent | Handren Assoc. | accessdata.fda.gov |
| November 10, 1994 | K944566 | VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 24, 2016 | 75066 | Class II | Terminated | Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related dise | Out of Specification Microbiological test results | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Tissue Culture
- All makers of Coronavirus Antigen Detection Test System.
- All makers of Micro Pipette
- All makers of Stain, Papanicolau
- All makers of Safranin
- All makers of Culture Media, Non-Propagating Transport
Updated June 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.