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Instrumentation Laboratory (Werfen)

526 Route 303, Orangeburg, NY 10962

ACTIVELAST SEEN IN FEDERAL DATA OCT 2026 · 3 SOURCES

Operating signal within 12 months from two or more independent sources.

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What they make

In-Vitro Diagnostic Substance Manufacturing325413

Products

Made or handled here · 44
Acid, Lactic, Enzymatic Method · Activated Partial Thromboplastin · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use · Anti-Factor Xa Activity Test System, Apixaban · Antithrombin Iii Quantitation · Assay, Carboxyhemoglobin · Assay, Heparin · Assay, Oral Direct Thrombin Inhibitor · Bilirubin (Total And Unbound) In The Neonate Test System · Calculator/Data Processing Module, For Clinical Use · Calibrator, Multi-Analyte Mixture · Calibrator, Primary · Calibrators, Drug Specific · Calibrator, Secondary · Control, Hematocrit · Control, Plasma, Abnormal · Diazo Colorimetry, Bilirubin · Drug Specific Control Materials · Electrode, Ion Specific, Calcium · Electrode, Ion-Specific, Chloride · Electrode, Ion Specific, Potassium · Electrode, Ion Specific, Sodium · Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph · Enzymatic, Carbon-Dioxide · Enzymatic Method, Creatinine · Fluorometric, Calcium · Glucose Oxidase, Glucose · Instrument, Hematocrit, Automated · Multi-Analyte Controls, All Kinds (Assayed) · Oximeter To Measure Hemoglobin · Plasma, Coagulation Control · Plasma, Coagulation Factor Deficient · Plasma, Control, Normal · Quality Control Material, Genetics, Dna · Reagent, Russel Viper Venom · System, Fibrinogen Determination · System, Hemoglobin, Automated · System, Multipurpose For In Vitro Coagulation Studies · Test, Fibrinogen · Test, Qualitative And Quantitative Factor Deficiency · Test, Thrombin Time · Test, Time, Partial Thromboplastin · Test, Time, Prothrombin · Urease And Glutamic Dehydrogenase, Urea Nitrogen
Where these came from
44 from FDA device registration · Federal registry
FDA device establishment 2431530, product code KHP; proprietary names: GEM Premier ChemSTAT PAK, GEM Premier ChemSTAT

Where it is

41.05626, -73.94745 · CENSUS TIGER
COUNTY
METRO AREA
ON GOOGLE MAPS
STREET VIEW

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Every listed plant in Rockland County

Also at this address

No other federal record shares this street address.

Where this record comes from

3 sources hold this plant, and 7 fields on this page come from them. Each line is one agency’s own record of it: the identifier it is filed under, whether that record shows the plant operating or only that it exists, and when the register first and last saw it there.

EPA cross-references this facility in BR, FIS, NPDES, RCRAINFO · EPA site type STATIONARY.

  • FDA device establishment registrationsOPERATING
    first seen AUG 2026 · last seen OCT 2026
  • OSHA injury and illness reportsOPERATING
    Record 956358 · first seen DEC 2025 · last seen DEC 2025
  • EPA Facility Registry ServiceEXISTENCE
    Record 110000885695 · first seen JAN 2016 · last seen JAN 2016

ALSO RECORDED ASINSTRUMENTATION LABORATORY-DIAGNOSTICS

IN ROCKLAND COUNTY14 other plants share this one’s industry (Pharmaceutical and Medicine Manufacturing, NAICS 3254); 5 of them have a size band on record.

What each source says

Every field below, as each source filed it. The value this page shows is marked; where the sources disagree, the field says so. Status is computed from independent sources; nothing here is self-reported unless marked Claimed.

Name
EPA: INSTRUMENTATION LABORATORY-DIAGNOSTICS · JUL 2026
Street address
EPA: 526 ROUTE 303 · JUL 2026
City
EPA: ORANGEBURG · JUL 2026
State
EPA: NY · JUL 2026
County (FIPS code)
EPA: 36087 · SEP 2026
CoordinatesSOURCES DISAGREE
Census geocoder: 41.056260866419,-73.947453930952 · JUL 2026 · ON THIS PAGE
EPA: 41.055027,-73.947014 · JUL 2026
Employees (band)
OSHA: 100-499 · DEC 2025

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