FDA UDI
In Commercial Distribution
🇺🇸 United States
Accula SARS-CoV-2 Test
DI: B540COV41000
·
Model: COV4100
·
MESA BIOTECH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Accula SARS-CoV-2 Test
- Primary DI
- B540COV41000
- Version / Model
- COV4100
- Catalog Number
- COV4100
- Company Name
- MESA BIOTECH, INC.
- Labeler DUNS
- 056865474
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-13
- Public Version
- 1
- Public Version Date
- 2020-04-21
- Public Version Status
- New
- Public Device Record Key
- f0681851-1434-4e82-820a-6d643e6d41e5
Device Description
The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64747 | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B540COV41000 | HIBCC |
Customer Contacts
- Phone
- 858-800-4929
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius