FDA UDI
In Commercial Distribution
🇺🇸 United States
QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit
DI: 08809115900401
·
Model: OI-01SQ-C1
·
OSANG HEALTHCARE Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit
- Primary DI
- 08809115900401
- Version / Model
- OI-01SQ-C1
- Catalog Number
- RCQC110ENA1
- Company Name
- OSANG HEALTHCARE Co., Ltd.
- Labeler DUNS
- 688195374
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 2
- Public Version Date
- 2025-03-31
- Public Version Status
- Update
- Public Device Record Key
- ee164606-a5df-4208-85c8-674177f2d1f7
Device Description
10 Sets / Box
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 |
|---|---|---|---|---|
| MJZ | Kit, Direct Antigen, Positive Control | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48247 | Multiple-genus respiratory virus antigen IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809115900401 | GS1 |
Customer Contacts
- Phone
- 1-844-760-0556
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius