Retic-Chex II 285204
by Streck
Retic-Chex II 285204 is a Class II device made by Streck, listed in FDA GUDID since 19 Sep 2016 (UDI-DI 20844509000383), registry data as of 23 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 | Number20844509000383 | Date19 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 20844509000383
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Retic-Chex II
- Generic name
- Reticulocyte count IVD, control
- Model / Ref / Catalog
- 285204
- Description
- A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 4 vials of level 2.
- Primary DI / UDI-DI
- 20844509000383
- FDA product code
- JPK
- GMDN term
- Reticulocyte count IVD, control
- Device class
- Class II
- Regulation number
- 864.8625
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 1.0 Milliliter
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