WebDevice Name: Alere Afinion™ HbA1c and Alere Afinion™ AS100 Analyzer Product code Classification Regulation Section Classification Panel LCP Class II 21 CFR 864.7470 Hematology JQT Class I 21 CFR 862.2400 Chemistry Predicate Devices: The predicate devices are the following legally marketed devices: Alere Afinion™ HbA1c and Alere … WebMar 2, 2024 · Module name changed from “Alere Afinion™ AS100” to “Alere Afinion™” with support of the Alere Afinion™ 2 Device. Hardware Version and IP Address are now displayed on the Device Management Page for each Afinion device. This allows end users the ability to identify which type of Afinion device is communicating if they have
Class 2 Device Recall Afinion 2, Afinion AS100 analyzer - Food …
WebAutomatic self-check system: The Alere Afinion™ AS100 analyzer eliminates erroneous results with integrated error detection and self-check systems Easy handling steps Color touch display USB connection for optional barcode reader and printer Connectivity solutions that support POCT1-A QC and operator lockout WebView Full Comparison. #1139091. 51. Abbott Rapid Dx North America LLC #1116985. Point-of-Care Analyzer Afinion™ 2 CLIA Waived (HbA1c) The Afinion™ 2 Analyzer is a compact, rapid, multi-assay analyzer that …. The analyzer is designed to enable simple and fast on-the-spot testing …. The Afinion™ 2 Analyzer automatically transfers ... how to crimp bnc connectors
Alere Afinion AS100 Analyzer US - nwprimarycare
WebJul 22, 2016 · The Alere Afinion™ HbA1c Dx test is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human … WebNov 1, 2024 · • Read the entire Afinion ™ HbA1c Quick Guide before testing patient samples or controls. • See the Alere Afinion ™ AS100 Analyzer User Manual for more information about the operation of the Analyzer and Test Cartridge. • See the Afinion HbA1c Package Insert for more information about the HbA1c assay. WebFor use with the Afinion™ AS100 Analyzer Please consult the Afinion™ AS100 Analyzer User Manual for information related to the general operation of the Analyzer and Afinion™ Test Cartridge handling. Technical Support The manufacturer provides a toll free line for technical support.Call 1-877-4-Afinion or 1-877-423-4646. how to crimp cable sleeve