Audited Supplier
HBA-101
Hba1c Analyzer Meter
CE, ISO13485
OEM/SoyMed
61.5mm*122.9mm*24.5mm
China
Product Description
What is HbA1c
1. HbA1c, formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose, reflects average glycemia over several months.
2. As a primary technique to assess the effectiveness of diabetes management, HbA1c has strong predictive value for diabetes complications. Lowering HbA1c has been shown to reduce complications.
3. HbA1c≥6.5% (48 mmol/mol) is one of the criteria for diabetes diagnosis. Normal HbA1c range is 4.0-5.7% (20-39 mmol/mol), while 5.7-6.4% (39-46 mmol/mol) is considered as prediabetes.
4. Point-of-care testing for HbA1c provides the opportunity for more timely treatment changes.
Specifications Technical Parameters
Testing Principle Boronate Affinity Chromatography
Testing Item Glycohemoglobln (HbA1c)
Testing Range 4%-14%
Precision CV<3% (HbA1c 4. 0%-6. 5%)
blood sample Flngertlp blood or Venous blood (EDTA Antlcoagulation)
Blood Volume About 3uL
Testing Time About 5 minutes
Data Unit Set in advance the data unit NGSP% IFCC mmol/mol
Voice Prompt Voice prompt In the whole process
Data Storage 1000 lest results
Data Port Mini USB data interface can be connected with Hlmls system/thermal printer
Bluetooth Function Optional
Power Required AAA battery ×4
Analyzer Dimension 61. 5mm x 122. 9mm x 24. 5mm
Screen Size 47mm x 32mm
Weight 112g (Does not include battery)
Operating Condition Temperature 10ºC-40ºC; Humidity 30%-70%
Storage Condition Temperature-10ºC-50ºC; Humidity <80%
1. HbA1c, formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose, reflects average glycemia over several months.
2. As a primary technique to assess the effectiveness of diabetes management, HbA1c has strong predictive value for diabetes complications. Lowering HbA1c has been shown to reduce complications.
3. HbA1c≥6.5% (48 mmol/mol) is one of the criteria for diabetes diagnosis. Normal HbA1c range is 4.0-5.7% (20-39 mmol/mol), while 5.7-6.4% (39-46 mmol/mol) is considered as prediabetes.
4. Point-of-care testing for HbA1c provides the opportunity for more timely treatment changes.
Specifications Technical Parameters
Testing Principle Boronate Affinity Chromatography
Testing Item Glycohemoglobln (HbA1c)
Testing Range 4%-14%
Precision CV<3% (HbA1c 4. 0%-6. 5%)
blood sample Flngertlp blood or Venous blood (EDTA Antlcoagulation)
Blood Volume About 3uL
Testing Time About 5 minutes
Data Unit Set in advance the data unit NGSP% IFCC mmol/mol
Voice Prompt Voice prompt In the whole process
Data Storage 1000 lest results
Data Port Mini USB data interface can be connected with Hlmls system/thermal printer
Bluetooth Function Optional
Power Required AAA battery ×4
Analyzer Dimension 61. 5mm x 122. 9mm x 24. 5mm
Screen Size 47mm x 32mm
Weight 112g (Does not include battery)
Operating Condition Temperature 10ºC-40ºC; Humidity 30%-70%
Storage Condition Temperature-10ºC-50ºC; Humidity <80%
