23-111-438
Germaine™ Laboratories Rapid Check™ Respiratory Syncytial Virus RSV Antigen Test
Manufacturer: Germaine™ Laboratories
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Control Sets
Positive and Negative
CE Marker
No
DoA Calibrators
No
Sample Type
Nasopharyngeal Swabs, Nasal Aspirates
For Use With (Application)
Testing children less than 6 years old and adults over 60 years.
Quantity
20 tests/kit
CPT Code
87807
Clia Complexity
Waived
Format
Test Kit
Type
RSV Rapid Test
Includes
20 Individually packaged test devices, Nasopharyngeal Swabs with each kit, 1 R1 (Extraction Reagent Solution) 2 mL, 20 Extraction Tubes, 40 Disposable Pipettes, 1 PC (Positive Control Reagent) 1.0 mL, 1 NC (Negative Control Reagent) 1.0 mL, 1 Instructions for Use
Test Time
15 mins.
Related Products
Description
- Rapid, qualitative detection of respiratory syncytial virus fusion protein in nasopharyngeal swabs or nasal aspirate specimens in children less than 6 years and adults over 60
- Intended as an aid in the rapid laboratory diagnosis of acute respiratory syncytial virus infection in patients with such symptoms
- 510(k) Cleared and CLIA Waived for Prescription Use Detection of fusion protein of respiratory syncytial virus Nasopharyngeal swab and nasal aspirate specimen Each kit includes: 20 Individually packaged test devices Nasopharyngeal Swabs with each kit 1 R1 (Extraction Reagent Solution) 2 mL 20 Extraction Tubes 40 Disposable Pipettes 1 PC (Positive Control Reagent) 1.0 mL 1 NC (Negative Control Reagent) 1 Instructions for Use Premier Test Performance: Positive % Agreement: 93
- 9% Negative % Agreement: 97.7%
SAFETY INFORMATION
- ShelfLife : 24 mos. from Manufacture Date
Compare Similar Items
Show Difference
Control Sets: Positive and Negative
CE Marker: No
DoA Calibrators: No
Sample Type: Nasopharyngeal Swabs, Nasal Aspirates
For Use With (Application): Testing children less than 6 years old and adults over 60 years.
Quantity: 20 tests/kit
CPT Code: 87807
Clia Complexity: Waived
Format: Test Kit
Type: RSV Rapid Test
Includes: 20 Individually packaged test devices, Nasopharyngeal Swabs with each kit, 1 R1 (Extraction Reagent Solution) 2 mL, 20 Extraction Tubes, 40 Disposable Pipettes, 1 PC (Positive Control Reagent) 1.0 mL, 1 NC (Negative Control Reagent) 1.0 mL, 1 Instructions for Use
Test Time: 15 mins.
Control Sets:
Positive and Negative
CE Marker:
No
DoA Calibrators:
No
Sample Type:
Nasopharyngeal Swabs, Nasal Aspirates
For Use With (Application):
Testing children less than 6 years old and adults over 60 years.
Quantity:
20 tests/kit
CPT Code:
87807
Clia Complexity:
Waived
Format:
Test Kit
Type:
RSV Rapid Test
Includes:
20 Individually packaged test devices, Nasopharyngeal Swabs with each kit, 1 R1 (Extraction Reagent Solution) 2 mL, 20 Extraction Tubes, 40 Disposable Pipettes, 1 PC (Positive Control Reagent) 1.0 mL, 1 NC (Negative Control Reagent) 1.0 mL, 1 Instructions for Use
Test Time:
15 mins.
Control Sets: __
CE Marker: No
DoA Calibrators: __
Sample Type: Urine
For Use With (Application): In Vitro Diagnostic Use
Quantity: __
CPT Code: __
Clia Complexity: Waived
Format: Cassette
Type: Fentanyl Test Cassette
Includes: __
Test Time: __
Control Sets:
__
CE Marker:
No
DoA Calibrators:
__
Sample Type:
Urine
For Use With (Application):
In Vitro Diagnostic Use
Quantity:
__
CPT Code:
__
Clia Complexity:
Waived
Format:
Cassette
Type:
Fentanyl Test Cassette
Includes:
__
Test Time:
__
Control Sets: Positive and Negative Controls Included.
CE Marker: No
DoA Calibrators: No
Sample Type: Nasopharyngeal Swabs/Nasal Aspirates
For Use With (Application): For Children Less than 6 Years Old and Adults Over 60 Years
Quantity: 1 Kit
CPT Code: 87807
Clia Complexity: Waived
Format: __
Type: RSV Rapid Test
Includes: 20 Individually Packaged Test Devices, Nasopharyngeal Swabs with Each Kit, 1 R1 (Extraction Reagent Solution) 2 mL, 20 Extraction Tubes, 40 Disposable Pipettes, 1 PC (Positive Control Reagent) 1.0 mL, 1 NC (Negative Control Reagent) 1.0 mL, and 1 Instructions for Use.
Test Time: 15 min.
Control Sets:
Positive and Negative Controls Included.
CE Marker:
No
DoA Calibrators:
No
Sample Type:
Nasopharyngeal Swabs/Nasal Aspirates
For Use With (Application):
For Children Less than 6 Years Old and Adults Over 60 Years
Quantity:
1 Kit
CPT Code:
87807
Clia Complexity:
Waived
Format:
__
Type:
RSV Rapid Test
Includes:
20 Individually Packaged Test Devices, Nasopharyngeal Swabs with Each Kit, 1 R1 (Extraction Reagent Solution) 2 mL, 20 Extraction Tubes, 40 Disposable Pipettes, 1 PC (Positive Control Reagent) 1.0 mL, 1 NC (Negative Control Reagent) 1.0 mL, and 1 Instructions for Use.
Test Time:
15 min.
Control Sets: __
CE Marker: No
DoA Calibrators: __
Sample Type: Urine
For Use With (Application): DOA Testing
Quantity: 25/Cs.
CPT Code: __
Clia Complexity: Waived
Format: Drug Cup
Type: Drug Cup
Includes: 25/Cs., Gloves, Security Seals, Package Insert
Test Time: Results in 5 Minutes
Control Sets:
__
CE Marker:
No
DoA Calibrators:
__
Sample Type:
Urine
For Use With (Application):
DOA Testing
Quantity:
25/Cs.
CPT Code:
__
Clia Complexity:
Waived
Format:
Drug Cup
Type:
Drug Cup
Includes:
25/Cs., Gloves, Security Seals, Package Insert
Test Time:
Results in 5 Minutes