Rapid SARS-CoV-2 Antigen Test Card
Basic Information
- Brand Name
- Rapid SARS-CoV-2 Antigen Test Card
- Primary DI
- 00855636003716
- Version / Model
- 1N40C5-1-US-BS
- Catalog Number
- 1N40C5-1-US-BS
- Company Name
- LUMIQUICK DIAGNOSTICS, INC.
- Labeler DUNS
- 790175165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-12
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- fad87d12-433c-46aa-a16f-606d478d28f3
Device Description
The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 and older, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QKP | Coronavirus Antigen Detection Test System. | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64787 | SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00855636003723 | GS1 | Kit | 2 | In Commercial Distribution | |
| Primary | 00855636003716 | GS1 | ||||
| Package | 00855636003730 | GS1 | Kit | 4 | In Commercial Distribution | |
| Package | 00855636003747 | GS1 | Kit | 5 | In Commercial Distribution | |
| Package | 00855636003754 | GS1 | Kit | 8 | In Commercial Distribution | |
| Package | 00855636003761 | GS1 | Kit | 10 | In Commercial Distribution | |
| Package | 00855636003778 | GS1 | Kit | 20 | In Commercial Distribution | |
| Package | 00855636003785 | GS1 | Kit | 40 | In Commercial Distribution |
Customer Contacts
- Phone
- 4088550061
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius