Xn Check 213499
Xn Check 213499 is a Class II device made by Sysmex Corporation, listed in FDA GUDID since 5 Aug 2016 (UDI-DI 14987562460301), registry data as of 12 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number14987562460301 | Date5 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 14987562460301
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Xn Check
- Generic name
- Full blood count IVD, control
- Model / reference
- 213499
- Primary DI / UDI-DI
- 14987562460301
- FDA product code
- JPK
- GMDN term
- Full blood count IVD, control
- Device class
- Class II
- Regulation number
- 864.8625
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 3 Milliliter
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