FDA UDI
In Commercial Distribution
🇺🇸 United States
Genedrive(R)96 SARS-CoV2-kit
DI: 05060654860059
·
Model: 1
·
GENEDRIVE DIAGNOSTICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Genedrive(R)96 SARS-CoV2-kit
- Primary DI
- 05060654860059
- Version / Model
- 1
- Catalog Number
- ID-CoV2-01-LPU
- Company Name
- GENEDRIVE DIAGNOSTICS LTD
- Labeler DUNS
- 239114809
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-19
- Public Version
- 1
- Public Version Date
- 2021-03-01
- Public Version Status
- New
- Public Device Record Key
- c4f9d6f8-1651-4134-9ce6-0d7447a71274
Device Description
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Roche LightCycler 11 instrument .
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QLT | Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices | 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 | 05060654860059 | GS1 | ||||
| Package | 05060654860134 | GS1 | Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 855 678 7768
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius