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Device Description : Protinol protein-based osmolality controls are intended for use in evaluating th Protinol protein-based osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used daily to monitor the precision of the testing procedure for osmolality, and to conduct laboratory proficiency testing. Protinol protein-based controls are formulated to mimic reportable ranges (low-to-high levels) for human serum.
Device Class : 1
Duns Number: 125006353
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Osmolality Linearity Set is designed to help clinical laboratories easily mo The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and fulfill CLIA requirements for verifying the reportable range of a laboratory method.
Device Class : 1
Duns Number: 125006353
Premarket Exempt : Yes
Prescription Use : No
Device Description : For In vitro diagnostic use. The Advanced™ Micro-Sample Test Kit conveniently s For In vitro diagnostic use. The Advanced™ Micro-Sample Test Kit conveniently supplies the consumables needed for osmolality testing: 500 sampler tips, 500 chamber cleaners, and one replacement plunger wire.
Device Class : 1
Duns Number: 125006353
Premarket Exempt : Yes
Prescription Use : No
Device Description : Advanced Instruments Ease-Eject 20-Microliter Sampler for use with Advanced Inst Advanced Instruments Ease-Eject 20-Microliter Sampler for use with Advanced Instruments Osmo1® Single-Sample Micro-Osmometer or Advanced Instruments OsmoTECH® Single-Sample Micro-Osmometer
Device Class : 1
Duns Number: 125006353
Premarket Exempt : Yes
Prescription Use : No
Device Description : The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluen The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluent and reagent counts exceed the acceptance criteria
Device Class : 2
Duns Number: 125006353
Premarket Exempt : Yes
Prescription Use : No
Device Description : With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate an With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of-use for efficient patient sample analysis. Easily maintain regulatory compliance while ensuring the security and integrity of patient data with the Osmo1. Best for labs that process 10 or fewer samples per day or prefer a direct-draw instrument.
Device Class : 1
Duns Number: 125006353
Premarket Exempt : Yes
Prescription Use : No
Device Description : Supporting efficient workflows for mid- to high-volume clinical chemistry labs, Supporting efficient workflows for mid- to high-volume clinical chemistry labs, the OsmoPRO features a convenient carousel design that handles up to 20 samples, an intuitive touchscreen interface, and industry-leading performance. Simple, reliable, and efficient, the OsmoPRO delivers accurate and precise analysis of patient samples for maximum productivity.
Device Class : 1
Duns Number: 125006353
Premarket Exempt : Yes
Prescription Use : No
Device Description : Samples tubes for use with the OsmoPRO® Multi-Sample Micro-Osmometer
Device Class : 1
Duns Number: 125006353
Premarket Exempt : Yes
Prescription Use : No
Device Description : Advanced Instruments probe wiper rings are used to mitigate sample carry-over du Advanced Instruments probe wiper rings are used to mitigate sample carry-over during osmolality testing
Device Class : 1
Duns Number: 125006353
Premarket Exempt : Yes
Prescription Use : No
Device Description : Advanced Instruments pipettes are used to facilitate sample management while usi Advanced Instruments pipettes are used to facilitate sample management while using Advanced Instruments osmometers
Device Class : 1
Duns Number: 125006353
Premarket Exempt : Yes
Prescription Use : No