INSTRUMENTATION LABORATORY CO. - Devens
Devens, MA, US
INSTRUMENTATION LABORATORY CO. - Devens appears in FDA device records in Devens, MA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 1
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3037000637 | 3037000637 | INSTRUMENTATION LABORATORY CO. - Devens | 11 Grant Road, Devens, MA 01434 US | 2026 | and 43 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- GFOActivated Partial Thromboplastin
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- QLUAnti-Factor Xa Activity Test System, Apixaban
- KFGAntiserum, Positive Control, Aspergillus Spp.
- JBQAntithrombin Iii Quantitation
- GHSAssay, Carboxyhemoglobin
- KFFAssay, Heparin
- QBGAssay, Oral Direct Thrombin Inhibitor
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- JQPCalculator/Data Processing Module, For Clinical Use
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- GLKControl, Hematocrit
- GGCControl, Plasma, Abnormal
- CIGDiazo Colorimetry, Bilirubin
- LASDrug Specific Control Materials
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- JFYEnzymatic Method, Creatinine
- KHSEnzymatic, Carbon-Dioxide
- DBTFactor Xiii A, S, Antigen, Antiserum, Control
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- JFOFluorometric, Calcium
- CGAGlucose Oxidase, Glucose
- GKPInstrument, Coagulation, Automated
- GKFInstrument, Hematocrit, Automated
- OUGMedical Device Data System
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- GLYOximeter To Measure Hemoglobin
- GGNPlasma, Coagulation Control
- GJTPlasma, Coagulation Factor Deficient
- GIZPlasma, Control, Normal
- LCOPlatelet Factor 4 Radioimmunoassay
- GIRReagent, Russel Viper Venom
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KQJSystem, Fibrinogen Determination
- GKRSystem, Hemoglobin, Automated
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- MIDSystem, Test, Anticardiolipin Immunological
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- GISTest, Fibrinogen
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJATest, Thrombin Time
- GGWTest, Time, Partial Thromboplastin
- GJSTest, Time, Prothrombin
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- LPSUrinary Homocystine (Nonquantitative) Test System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain