Azer Scientific, Inc.
Morgantown, PA, US
AZER SCIENTIFIC, INC. appears in FDA device records in Morgantown, PA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Azer Scientific, Inc. in 2024.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009963993 | 3009963993 | AZER SCIENTIFIC, INC. | 701 Hemlock Rd, Morgantown, PA 19543 US | 2026 | and 53 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KEMAgent, Clearing
- IDAAlcian Blue
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KXGApplicator, Absorbent Tipped, Sterile
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- KERContainer, Embedding
- MMKContainer, Sharps
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- KDTContainer, Specimen Mailer And Storage, Sterile
- NNIContainer, Specimen, Non-Sterile
- FMHContainer, Specimen, Sterile
- KESCoverslips, Microscope Slide
- JSMCulture Media, Non-Propagating Transport
- JSGCulture Media, Non-Selective And Non-Differential
- MXTDevice, Accessory, Cooling Plate For Tissue Embedding Station
- JTCDevice, Microtiter Diluting/Dispensing
- GIFDiluent, Blood Cell
- IDWDispensers, Paraffin
- MRVDrink, Glucose Tolerance
- DKZEnzyme Immunoassay, Amphetamine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- HYBEosin Y
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- HYCFast Green
- LDYFixative, Formalin-Containing
- IGGFormaldehyde (Formalin, Formol)
- IFPFormalin, Neutral Buffered
- PPMGeneral Purpose Reagent
- HYFGiemsa Stain
- HYJHematoxylin
- HYKHematoxylin Harris'S
- NJTImmunohistochemistry Reagents And Kits
- MPOInfant Heel Warmer (Chemical Heat Pack)
- HYIIodine, Grams
- GGHIron Stains
- FXXMask, Surgical
- KEQMedia, Mounting, Water Soluble
- JRCMicro Pipette
- IDLMicrotome, Accessories
- IDOMicrotome, Rotary
- LEBMounting Media
- HZHOrange G
- LZAPolymer Patient Examination Glove
- HZTReagent, Schiff
- KSERefrigerator, Freezer, Blood Storage
- HZSSafranin
- KPASlide Stainer, Automated
- KEWSlides, Microscope
- KDXSolution, Decalcifier, Acid Containing
- IGBSolution, Formalin-Sodium Acetate
- HZJStain, Papanicolau
- LEDStains, Chemical Solution
- LEEStains, Dye Solution
- KQCStains, Hematology
- JTSStains, Microbiologic
- JQWStation, Pipetting And Diluting, For Clinical Use
- KJGTube, Tissue Culture
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- IAFWright'S Stain
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0330-2017 | Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes. | Out of Specification Microbiological test results | Class II | Terminated | |
| Z-0329-2017 | 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 disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes. | Out of Specification Microbiological test results | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain