MandeLab MSK-SCK001
MandeLab MSK-SCK001 is a Class I device made by Shenzhen Mandelab Co., Ltd, listed in FDA GUDID since 9 Dec 2022 (UDI-DI 06974760780011), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06974760780011 | Date9 Dec 2022 | StatusListed |
Official records
- AccessGUDID record 06974760780011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- MandeLab
- Generic name
- Oral/upper respiratory tract specimen collection kit IVD, clinical
- Model / reference
- MSK-SCK001
- Primary DI / UDI-DI
- 06974760780011
- FDA product code
- NNK
- GMDN term
- Oral/upper respiratory tract specimen collection kit IVD, clinical
- Device class
- Class I
- Regulation number
- 864.3250
- GUDID distribution status
- In Commercial Distribution
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