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A1Care HbA1c Cartridge
USD $23.00
Quantity:
Description

Description:
<p>This A1Care HbA1c Cartridge is used with the A1Care&trade; point-of-care (POC) analyzer designed to measure quantitatively the glycated hemoglobin (HbA1c) in whole blood.</p>
Product Bundled: []
Intended use: The A1Care HbA1c Cartridge is intended for quantitative measurement of glycated hemoglobin (HbA1c) and a ratio (% or mmol/mol) of HbA1c to total hemoglobin (tHb) in capillary and venous whole blood samples using the A1Care Analyzer.
Intended user: The A1Care HbA1c Cartridge is intended for in vitro diagnostic (IVD) use by healthcare professionals in laboratories such as physician’s offices, clinics, and hospitals for patients with diabetes.
Technology principle: Enzymatic Method
Sample type: Fresh capillary blood / Venous blood (acceptable anticoagulants include EDTA, heparin, fluoride/oxalate, and citrate)
Sampling volume: 2.5 µL
Test Time: 4min 20sec
Shelf life : 24 months
Packaging and labelling: 1 box for 10 kit (100 test Cartridges)
Storage conditions: Stable until the expiry date when stored at 1–30 °C in sealed foil pouches
Operating conditions: 10~32°C
Transportation : To kept at 1–30 °C during transportation
Cold chain requirements: Yes
Contents of kit: 10 test Cartridges and one insert. A foil package contains 1 test cartridge and 1 sample collector
Equipment required but not provided: Lancet, wipes
Name of manufacturer : i-SENS, Inc.
Country of manufacture: Republic of Korea
Ordering and Incoterms:
<p>&nbsp;</p> <ul> <li>The indicative starting price is FOB (Free on Board).</li> <li>Incoterms are negotiated between the supplier (or its local distributor) and the buyer.</li> <li>The final price is dependent on: Incoterms, order volume, freight, taxes, customs duties, handling fees and other applicable fees.&nbsp;</li> <li>Upon Request for Quotation, the buyer will receive a quotation with the applicable final price. Learn more about pricing on the DxConnect Marketplace at our helpdesk&nbsp;<u><a href="https://diagnostics.zendesk.com/hc/en-us/articles/4429547242521-Pricing-on-DxConnect-Marketplace" target="_blank">here</a></u>.</li> </ul>
Volume pricing:
<p>One i-SENS A1 care Analyser&nbsp;is&nbsp;provided free of charge when purchased in combination with 100 Tests A1Care HbA1c Cartridges per month for 24 months.</p>
Pricing Description: Price of a pack of 10 cartridges
Custom search fields: Diabetes, HbA1c
Stringent Regulatory Approval: CE IVD
Country Availability: Algeria, Chile, China, Egypt, Arab Rep., Germany, India, Iran, Islamic Rep., Iraq, Jordan, Kenya, Kuwait , Malaysia, Mexico, Myanmar, Nepal, New Zealand, Peru, Philippines, Romania, Saudi Arabia, South Africa, Thailand, Vietnam, Yemen, Rep.
Test Design : Cartridge
Device Design : Bench-top
Reporting units : IFCC (mmol/mol) / NGSP/DCCT (%)
Test and Sampling Procedure : Prepare venous whole blood (e.g., samples from blood collection tubes) or capillary whole blood (samples from fingers) or QC material (A1Care HbA1c Control Solution, provided at two levels - normal and abnormal). After sampling the blood, gently place the sample collector inside the cartridge.
Control : A1Care HbA1c Control Kit consists of two liquids: level 1 (normal) and level 2 (abnormal) (Please note that the Control Kit can be viewed and purchased here)
Calibration : Calibration data are established for each lot of test cartridges and then stored in the barcode on the cartridge label. The analyzer will scan its calibration data automatically during testing. When stored correctly according to the manual, the performance of cartridge is guaranteed until its expiry date.
Reportable range: 4–15 % (NGSP) or 20–140 mmol/mol (IFCC)
Limitations: Total hemoglobin concentration: lower than 7 g/dL or above 24 g/dL. Samples such as very high levels of hemoglobin F (>10 %), hemolytic anemia, polycythemia, homozygous HbS and HbC can result in decreased life span of the red blood cells, which causes HbA1c results to be lower than expected.
Precision: CV <3%
Interference: No interference for HbA1c variants except more 10% HbF.
IFCC Certified: Yes
NGSP Certified: Yes
Dimensions (mm): 175*150*115 mm/Kit (10 tests)


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