Matrix Plus Cholestereol Reference Kit 9550
by Verichem Laboratories, Inc.
Matrix Plus Cholestereol Reference Kit 9550 is a Class II device made by Verichem Laboratories, Inc., cleared under FDA 510(k) K901113 on 29 Mar 1990 and listed in FDA GUDID since 29 Nov 2016 (UDI-DI 00852553007018), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00852553007018 | Date29 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK901113 | Date29 Mar 1990 | StatusActive |
Official records
- AccessGUDID record 00852553007018
- FDA 510(k) database K901113
Across registries
- FDA 510(k) K901113 decided 29 Mar 1990 Active
- FDA GUDID UDI-DI 00852553007018 listed 29 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K901113
- Listed FDA GUDID 00852553007018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Matrix Plus Cholestereol Reference Kit
- Generic name
- Multiple clinical chemistry protein IVD, calibrator
- Model / reference
- 9550
- Primary DI / UDI-DI
- 00852553007018
- 510(k) Number
- FDA product code
- JIS
- GMDN term
- Multiple clinical chemistry protein IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 75 Milliliter
Similar devices
Other devices filed under FDA product code JIS (Calibrator, Primary).
- VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS by Ortho-Clinical Diagnostics
- THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 by Thermo Dma, Inc.
- 80 MG/DL GLUCOSE CONTROL by Boehringer Mannheim Corp.
- Access Total T4 II Calibrators C69048 by Beckman Coulter, Inc.
- TERUMO SENSIBEAD EIA PROGESTERONE KIT by TERUMO MEDICAL CORPORATION
- DC-LINEATE CAT. NO. SE-091 by Diagnostic Chemicals, Ltd. (Usa)
- C-REACTIVE PROTEIN TEST KIT by Sclavo, Inc.
- PHOSPHOROUS STANDARD #65073 by Emd Chemicals, Inc.
- Alinity 04V3801 by Abbott Ireland Diagnostics
- ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT. by E.I. Dupont DE Nemours & Co., Inc.