Product Classification / EMDN Category
FDA Product Code: JIX
Directory of devices assigned to product classification code JIX.
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1.Aptiva APS IgM Calibrator 1 (2x0.3mL)2. Aptiva APS IgM Calibrator 2 (2x0.3mL)3. Aptiva APS IgM Calibrator 3 (2x0.3mL)
Manufacturer: INOVA DIAGNOSTICS, INC.
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1.Aptiva APS IgA Calibrator 1 (2x0.3mL)2. Aptiva APS IgA Calibrator 2 (2x0.3mL)3. Aptiva APS IgA Calibrator 3 (2x0.3mL)
Manufacturer: INOVA DIAGNOSTICS, INC.
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1.Aptiva APS IgG Calibrator 1 (2x0.3mL)2. Aptiva APS IgG Calibrator 2 (2x0.3mL)3. Aptiva APS IgG Calibrator 3 (2x0.3mL)
Manufacturer: INOVA DIAGNOSTICS, INC.
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1. QUANTA Flash ENA7 Calibrator 1: Two (2) barcode labeled tubes 0.7 mL prediluted, ready to use. Calibrators contain human antibodies to ENA7 in buffer, protein stabilizers, and preservatives.2. QUANTA Flash ENA7 Calibrator 2: Two (2) barcode labeled tubes 0.7 mL prediluted, ready to use. Calibrators contain human antibodies to ENA7 in buffer, protein stabilizers, and preservatives."
Manufacturer: INOVA DIAGNOSTICS, INC.
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Lipase NG Cal must be used only for the calibration of Lipase NG kinetic colorimetric direct determination.For In Vitro Diagnostic use only.
Manufacturer: SENTINEL CH. SPA
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Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests listed in the Assigned Concentrations Table (TcA) using immunoturbidimetric methods. Use the calibrator according to the indicated analytical procedure. For in vitro diagnostic use only.
Manufacturer: SENTINEL CH. SPA
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Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests with immunoturbidimetric method.Use the Calibrator according to the indicated analytical procedure.For professional use only. For in vitro diagnostics use
Manufacturer: SENTINEL CH. SPA
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Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vitro diagnostic use only.
Manufacturer: SENTINEL CH. SPA
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Antiepileptic Drugs XT2
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Saliva Calibrator Set MassChrom Cortisol, Cortisone
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Serum Calibrator Set MassChrom 25-OH-Vitamin D3/D2 in serum/plasma
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Urine Calibrator Set MassChrom Amino Acid Analysis in urine
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Antimycotic Drugs/EXTENDED
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassChrom Amino Acid Analysis in plasma/serum
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Whole Blood Calibrator SetMassChrom Vitamins B1 and B6
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Neuroleptics 2/ EXTENDED2
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Antibiotics
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Whole Blood Calibration Standard Vitamins B1/B6
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Serum Calibration Standard 25-OH-Vitamin D3/D2
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Urine Calibration Standard o-Cresol, p-Cresol, Phenol
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Urine Calibration Standard t,t-Muconic Acid
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Extended Benzodiazepines
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Itraconazole, Posaconazole, Voriconazole
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Serum Calibration Standard Rufinamide, Felbamate, Lacosamide
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Perazine, Quetiapine, Citalopram
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Alprazolam, Trazodone
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Clobazam, Norclobazam
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Urine Calibration Standard Catecholamines
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Catecholamines
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Clozapine, Norclozapine
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Tricyclic Antidepressants
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Benzodiazepines
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Benzodiazepines, Tricyclic Antidepressants
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Mycophenolic Acid
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Whole Blood Calibration Standard Vitamins B1/B2
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Vitamin B6
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Serum Calibration Standard Vitamins A and E
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Whole Blood Calibration Standard Vitamin B6
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Serum Calibration Standard Sultiame, Lamotrigine
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Serum Calibration Standard Pregabalin, Vigabatrin, Gabapentin
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Serum Calibration Standard Trileptal, Zonisamide
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Amiodarone, Desethylamiodarone
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Serum Calibration Standard Antiepileptic Drugs / High Resolution
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Serum Calibration Standard Antiepileptic Drugs
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Urine Calibration Standard Metanephrines
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Urine Calibration Standard VMA, HVA, 5-HIAA
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Olanzapine, Desmethylolanzapine
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Urine Calibration Standard Occupational Medicine
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set Antibiotics
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Antidepressants 2/ Psychostimulants/EXTENDED
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Antiepileptic Drugs/EXTENDED
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Saliva Calibrator Set MassChrom Cortisol, Cortisone
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Serum Calibrator Set MassChrom Steroid Panel 1 and Panel 2
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Urine Calibrator Set MassChrom Total Metanephrines
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Urine Calibrator Set MassChrom Catecholamines, free Metanephrines, Serotonin
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Urine Calibrator Set MassChrom VMA, HVA, 5-HIAA
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Plasma Calibrator Set MassChrom Free Metanephrines
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Neuroleptics 1/ EXTENDED
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Antidepressants 1/EXTENDED
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Serum Calibrator Set MassChrom Steroid Panel 2
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Serum Calibrator Set MassChrom Steroid Panel 1
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Neuroleptics 2/ EXTENDED
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Plasma Calibrator Set Mycophenolic Acid/Glucuronide
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Serum Calibrator Set MassChrom 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Antiarrhythmic Drugs
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Plasma Calibrator Set MassTox Anti-HIV Drugs
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Plasma Calibrator Set Mycophenolic Acid/Glucuronide
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Antimycotic Drugs
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Tricyclic Antidepressants TCA 2
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Tricyclic Antidepressants TCA 1
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Benzodiazepines 2
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassTox Benzodiazepines 1
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Serum Calibrator Set MassChrom 25-OH-Vitamin D3/D2
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set Mycophenolic Acid/Glucuronide
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set Itraconazole, Posaconazole, Voriconazole
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Whole Blood Calibrator Set MassTox Immunosuppressants
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set Imatinib, Dasatinib, Nilotinib
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Serum Calibrator Set MassChrom 25-OH-Vitamin D3/D2
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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6PLUS1 Multilevel Whole Blood Calibrator Set MassTox Immunosuppressants
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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