I-STAT ALINITY SYSTEM KIT

I
i-STAT - 02R60-05

A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QAT

Device Name: Brain Trauma Assessment Test

Device Class: 2

Physical State: Assay kit containing antibodies, reagents and plate/or beads. General microplate reader or automated instrument with software

Definition: Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Enzyme-linked immunosorbent assay

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Blood

Regulation Number: 866.5830

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00054749005611

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A