23-315-124
Meridian Bioscience™ Illumigene Mycoplasma Direct DNA Amplification Assay
Manufacturer: Meridian Bioscience™
The price for this product is unavailable. Please request a quote
Certifications/Compliance
CE Marked, FDA Cleared
Description
FDA Cleared
Clia Complexity
Moderate
Sensitivity
96%
Specificity
0.977
Content And Storage
2°C to 27°C
CE Marker
Yes
Sample Type
Throat Swab
Quantity
50 Tests
Related Products
Description
- illumigene kits were rebranded as Alethia
- Product is identical only the name is different
- No validation of Alethia is needed if currently using illumigene version
- If discontinued illumigene kits are ordered the Alethia version will ship
- New Number is 23029012 Results in less than 1 hour Detects Mycoplasma pneumoniae on day 1 of symptoms Simple sample preparation from throat swabs High sensitivity and specificity 0.0% Invalid Rate Quicker initiation of appropriate patient care Expanded molecular menu No capital expense or service contract required Small footprint, easily adaptable to any laboratory
SAFETY INFORMATION
- ShelfLife : 18 Months
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Certifications/Compliance: CE Marked, FDA Cleared
Description: FDA Cleared
Clia Complexity: Moderate
Sensitivity: 96%
Specificity: 0.977
Content And Storage: 2°C to 27°C
CE Marker: Yes
Sample Type: Throat Swab
Quantity: 50 Tests
Certifications/Compliance:
CE Marked, FDA Cleared
Description:
FDA Cleared
Clia Complexity:
Moderate
Sensitivity:
96%
Specificity:
0.977
Content And Storage:
2°C to 27°C
CE Marker:
Yes
Sample Type:
Throat Swab
Quantity:
50 Tests
Certifications/Compliance: __
Description: __
Clia Complexity: __
Sensitivity: __
Specificity: __
Content And Storage: __
CE Marker: __
Sample Type: __
Quantity: __
Certifications/Compliance:
__
Description:
__
Clia Complexity:
__
Sensitivity:
__
Specificity:
__
Content And Storage:
__
CE Marker:
__
Sample Type:
__
Quantity:
__
Certifications/Compliance: FDA cleared
Description: __
Clia Complexity: Waived
Sensitivity: Flu A: 89.2% Flu B: 86.4%
Specificity: Flu A: 99.4%; Flu B: 99.0%
Content And Storage: 2°C to 30°C
CE Marker: __
Sample Type: __
Quantity: 32 tests (30 test + 2 controls)
Certifications/Compliance:
FDA cleared
Description:
__
Clia Complexity:
Waived
Sensitivity:
Flu A: 89.2% Flu B: 86.4%
Specificity:
Flu A: 99.4%; Flu B: 99.0%
Content And Storage:
2°C to 30°C
CE Marker:
__
Sample Type:
__
Quantity:
32 tests (30 test + 2 controls)
Certifications/Compliance: FDA cleared
Description: __
Clia Complexity: Moderate
Sensitivity: Flu A: 89.2% Flu B: 86.4%
Specificity: Flu A: 99.4%; Flu B: 99.0%
Content And Storage: 2°C to 30°C
CE Marker: __
Sample Type: __
Quantity: 30 Tests
Certifications/Compliance:
FDA cleared
Description:
__
Clia Complexity:
Moderate
Sensitivity:
Flu A: 89.2% Flu B: 86.4%
Specificity:
Flu A: 99.4%; Flu B: 99.0%
Content And Storage:
2°C to 30°C
CE Marker:
__
Sample Type:
__
Quantity:
30 Tests