23-111-399
Germaine™ Laboratories Status™ Covid-19/Flu A & B Rapid Test
Manufacturer: Germaine™ Laboratories
Select a Size
| Pack Size | SKU | Availability | Price |
|---|---|---|---|
| Pack of 25 | 23-111-399-Pack-of-25 | In Stock | ₹ 55,180.00 |
23-111-399 - Pack of 25
In Stock
Quantity
1
Base Price: ₹ 55,180.00
GST (18%): ₹ 9,932.40
Total Price: ₹ 65,112.40
Certifications/Compliance
FDA EUA Approved
Control Sets
Includes Positive/Negative Control Swabs
Detectable Analytes
SARS-CoV-2, Influenza A/B Nucleic Acids
Sensitivity
COVID-19: 93.9%, Flu A: 91.4%, Flu B: 87.6%
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%
Test Time
15 min.
Content And Storage
2° to 30°C (35° to 86°F)
CE Marker
Yes
Sample Type
Nucleocapsid Antigen from SARS-CoV2, Influenza A, and Influenza B
Disposable
Single-use
Quantity
25 Tests
Sterility
Non-sterile
Related Products
Description
- Status™ Covid-19/Flu A & B Test has been granted emergency use authorization (EUA) by the FDA for use at the point-of-care setting During the duration of the emergency this test can be performed in a patient care setting that is operating under a CUA Waiver, Certificate of Compliance, or Certificate of Accreditation 25 individually pouched test devices 1 test + 1 specimen = 3 Results Results in 15 minutes Made in USA Includes Extraction Reagent Capsules (25): 300 μL of phosphate buffer with detergents and preservative, for use with swab specimens Sterile Swabs (25): For specimen collection Positive Control Swab (1): Influenza A, B, and SARS-CoV-2 Antigen (Non-infective recombinant nucleocapsid protein) Negative Control Swab (1): Inactivated Group B Streptococcus Antigen (Non-infective) Package Insert/Instructions for Use (1) Quick Reference Instruction (1)
SAFETY INFORMATION
- ShelfLife : 8 Months from DOM
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Certifications/Compliance: FDA EUA Approved
Control Sets: Includes Positive/Negative Control Swabs
Detectable Analytes: SARS-CoV-2, Influenza A/B Nucleic Acids
Sensitivity: COVID-19: 93.9%, Flu A: 91.4%, Flu B: 87.6%
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%
Test Time: 15 min.
Content And Storage: 2° to 30°C (35° to 86°F)
CE Marker: Yes
Sample Type: Nucleocapsid Antigen from SARS-CoV2, Influenza A, and Influenza B
Disposable: Single-use
Quantity: 25 Tests
Sterility: Non-sterile
Certifications/Compliance:
FDA EUA Approved
Control Sets:
Includes Positive/Negative Control Swabs
Detectable Analytes:
SARS-CoV-2, Influenza A/B Nucleic Acids
Sensitivity:
COVID-19: 93.9%, Flu A: 91.4%, Flu B: 87.6%
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%
Test Time:
15 min.
Content And Storage:
2° to 30°C (35° to 86°F)
CE Marker:
Yes
Sample Type:
Nucleocapsid Antigen from SARS-CoV2, Influenza A, and Influenza B
Disposable:
Single-use
Quantity:
25 Tests
Sterility:
Non-sterile
Certifications/Compliance: __
Control Sets: __
Detectable Analytes: SARS-CoV-2
Sensitivity: 93.33% (28/30) (95% CI: 78.7%-98.2%)
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%)
Test Time: 15 min
Content And Storage: __
CE Marker: Yes
Sample Type: __
Disposable: Single-use
Quantity: 25 Pk.
Sterility: __
Certifications/Compliance:
__
Control Sets:
__
Detectable Analytes:
SARS-CoV-2
Sensitivity:
93.33% (28/30) (95% CI: 78.7%-98.2%)
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%)
Test Time:
15 min
Content And Storage:
__
CE Marker:
Yes
Sample Type:
__
Disposable:
Single-use
Quantity:
25 Pk.
Sterility:
__
Certifications/Compliance: __
Control Sets: __
Detectable Analytes: Respiratory Syncytial Virus (RSV)
Sensitivity: 0.97
Includes: Test Devices, Extraction Buffers and Tubes with Caps, Package Insert
Specificity: 0.98
Test Time: 15 minutes
Content And Storage: __
CE Marker: Yes
Sample Type: Nasopharyngeal Specimens
Disposable: __
Quantity: 30/Kit
Sterility: __
Certifications/Compliance:
__
Control Sets:
__
Detectable Analytes:
Respiratory Syncytial Virus (RSV)
Sensitivity:
0.97
Includes:
Test Devices, Extraction Buffers and Tubes with Caps, Package Insert
Specificity:
0.98
Test Time:
15 minutes
Content And Storage:
__
CE Marker:
Yes
Sample Type:
Nasopharyngeal Specimens
Disposable:
__
Quantity:
30/Kit
Sterility:
__
Certifications/Compliance: __
Control Sets: __
Detectable Analytes: Fentanyl (FEN)
Sensitivity: 10 ng/mL
Includes: 25 DipSticks per Kit, package insert.
Specificity: __
Test Time: 5 min.
Content And Storage: __
CE Marker: __
Sample Type: Liquids and Powders
Disposable: Single-use
Quantity: __
Sterility: __
Certifications/Compliance:
__
Control Sets:
__
Detectable Analytes:
Fentanyl (FEN)
Sensitivity:
10 ng/mL
Includes:
25 DipSticks per Kit, package insert.
Specificity:
__
Test Time:
5 min.
Content And Storage:
__
CE Marker:
__
Sample Type:
Liquids and Powders
Disposable:
Single-use
Quantity:
__
Sterility:
__