23-111-397
Assure Tech Co., Ltd. ASSURE COVID-19 IgG/IgM Rapid Test Device
Manufacturer: Assure Tech Co., Ltd.
Select a Size
| Pack Size | SKU | Availability | Price |
|---|---|---|---|
| Pack of 20 | 23-111-397-Pack-of-20 | In Stock | ₹ 23,140.00 |
23-111-397 - Pack of 20
In Stock
Quantity
1
Base Price: ₹ 23,140.00
GST (18%): ₹ 4,165.20
Total Price: ₹ 27,305.20
Content And Storage
Ambient
CE Marker
Yes
Detectable Analytes
SARS-CoV-2 IgG, IgM
Sensitivity
100% Combined Sensitivity
Disposable
Single-use
Quantity
20 Tests/Kit
Test Time
15 min.
Control Sets
This test requires a control (not included).
Clia Complexity
Waived (FDA, EUA)
Sample Type
Human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood
Type
Covid-19 Antibody
Includes
20 tests/kit, disposable pipettes, sterile safety lancets, alcohol prep pads, buffer, and a Pk. insert
Specificity
Combined specificity 98.8%
Related Products
Description
- Highly accurate, easy to use rapid test kit provides results in 15 minutes Includes: 20 tests/kit Disposable pipettes Sterile safety lancets Alcohol prep pads Buffer Package Insert Intended use: Rapid lateral flow chromatographic immunoassay for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood Identify individuals with an adaptive immune response to SARS-CoV-2 Limited use: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C
- 263a Note: Device should not be used to diagnose acute SARS-CoV-2 infection FDA EUA CLIA Waived authorization- fingerstick blood samples can now be tested in POC (Point of Care) setting such as doctor's offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing
- under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
SAFETY INFORMATION
- ShelfLife : 9 Months
Compare Similar Items
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Content And Storage: Ambient
CE Marker: Yes
Detectable Analytes: SARS-CoV-2 IgG, IgM
Sensitivity: 100% Combined Sensitivity
Disposable: Single-use
Quantity: 20 Tests/Kit
Test Time: 15 min.
Control Sets: This test requires a control (not included).
Clia Complexity: Waived (FDA, EUA)
Sample Type: Human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood
Type: Covid-19 Antibody
Includes: 20 tests/kit, disposable pipettes, sterile safety lancets, alcohol prep pads, buffer, and a Pk. insert
Specificity: Combined specificity 98.8%
Content And Storage:
Ambient
CE Marker:
Yes
Detectable Analytes:
SARS-CoV-2 IgG, IgM
Sensitivity:
100% Combined Sensitivity
Disposable:
Single-use
Quantity:
20 Tests/Kit
Test Time:
15 min.
Control Sets:
This test requires a control (not included).
Clia Complexity:
Waived (FDA, EUA)
Sample Type:
Human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood
Type:
Covid-19 Antibody
Includes:
20 tests/kit, disposable pipettes, sterile safety lancets, alcohol prep pads, buffer, and a Pk. insert
Specificity:
Combined specificity 98.8%
Content And Storage: 2° to 30°C (35° to 86°F)
CE Marker: Yes
Detectable Analytes: SARS-CoV-2, Influenza A/B Nucleic Acids
Sensitivity: COVID-19: 93.9%, Flu A: 91.4%, Flu B: 87.6%
Disposable: Single-use
Quantity: 25 Tests
Test Time: 15 min.
Control Sets: Includes Positive/Negative Control Swabs
Clia Complexity: __
Sample Type: Nucleocapsid Antigen from SARS-CoV2, Influenza A, and Influenza B
Type: __
Includes: Rapid Test Devices (25), Sterile Swabs (25), Positive Control Swab (1), Negative Control Swab (1), Package Insert/Instructions for Use (1), Quick Reference Instruction (1)
Specificity: COVID-19: 100%, Flu A: 95.7%, Flu B: 95.9%
Content And Storage:
2° to 30°C (35° to 86°F)
CE Marker:
Yes
Detectable Analytes:
SARS-CoV-2, Influenza A/B Nucleic Acids
Sensitivity:
COVID-19: 93.9%, Flu A: 91.4%, Flu B: 87.6%
Disposable:
Single-use
Quantity:
25 Tests
Test Time:
15 min.
Control Sets:
Includes Positive/Negative Control Swabs
Clia Complexity:
__
Sample Type:
Nucleocapsid Antigen from SARS-CoV2, Influenza A, and Influenza B
Type:
__
Includes:
Rapid Test Devices (25), Sterile Swabs (25), Positive Control Swab (1), Negative Control Swab (1), Package Insert/Instructions for Use (1), Quick Reference Instruction (1)
Specificity:
COVID-19: 100%, Flu A: 95.7%, Flu B: 95.9%
Content And Storage: __
CE Marker: Yes
Detectable Analytes: SARS-CoV-2
Sensitivity: 93.33% (28/30) (95% CI: 78.7%-98.2%)
Disposable: Single-use
Quantity: 25 Pk.
Test Time: 15 min
Control Sets: __
Clia Complexity: Waived (FDA, EUA)
Sample Type: __
Type: __
Includes: Test devices packaged individually in aluminum pouch, disposable test tube with buffer, filter cap, sterilized swabs, quick reference instruction, positive and negative control swabs
Specificity: 99.03% (102/103) (95% CI: 94.7%-99.8%)
Content And Storage:
__
CE Marker:
Yes
Detectable Analytes:
SARS-CoV-2
Sensitivity:
93.33% (28/30) (95% CI: 78.7%-98.2%)
Disposable:
Single-use
Quantity:
25 Pk.
Test Time:
15 min
Control Sets:
__
Clia Complexity:
Waived (FDA, EUA)
Sample Type:
__
Type:
__
Includes:
Test devices packaged individually in aluminum pouch, disposable test tube with buffer, filter cap, sterilized swabs, quick reference instruction, positive and negative control swabs
Specificity:
99.03% (102/103) (95% CI: 94.7%-99.8%)
Content And Storage: __
CE Marker: Yes
Detectable Analytes: Respiratory Syncytial Virus (RSV)
Sensitivity: 0.97
Disposable: __
Quantity: 30/Kit
Test Time: 15 minutes
Control Sets: __
Clia Complexity: Waived
Sample Type: Nasopharyngeal Specimens
Type: Respiratory Syncytial Virus Rapid Test
Includes: Test Devices, Extraction Buffers and Tubes with Caps, Package Insert
Specificity: 0.98
Content And Storage:
__
CE Marker:
Yes
Detectable Analytes:
Respiratory Syncytial Virus (RSV)
Sensitivity:
0.97
Disposable:
__
Quantity:
30/Kit
Test Time:
15 minutes
Control Sets:
__
Clia Complexity:
Waived
Sample Type:
Nasopharyngeal Specimens
Type:
Respiratory Syncytial Virus Rapid Test
Includes:
Test Devices, Extraction Buffers and Tubes with Caps, Package Insert
Specificity:
0.98