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Instrumentation Laboratory (Werfen)

526 Route 303, Orangeburg, NY 10962

ACTIVELAST SEEN IN FEDERAL DATA AUG 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
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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 FEDERAL SOURCES, 6 FIELDS

Every fact on this page traces to a public federal filing. The table below names which register holds this facility, whether that register proves the plant operates or only that it exists, and when each of them last saw it.

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

SourceEvidenceFirst seenLast seen
FDA DEVICESOPERATINGAUG 2026AUG 2026
OSHA ITAOPERATINGDEC 2025DEC 2025
EPA FRSEXISTENCEJAN 2016JAN 2016
FIELD BY FIELD — WHICH SOURCE SUPPLIED WHAT
FIELDSOURCESIGNAL
ADDRESS LINE1EPA FRSJUL 2026
CITYEPA FRSJUL 2026
EMPLOYEE BANDOSHA ITADEC 2025
GEOMCENSUS GEOCODERJUL 2026
GEOMEPA FRSJUL 2026
NAMEEPA FRSJUL 2026
STATEEPA FRSJUL 2026

Status is computed from independent sources; nothing here is self-reported unless marked Claimed.

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