Matrix Plus Chemistry Reference Kit 9500

• FDA 510(k) K901113 decided 29 Mar 1990 Active
• FDA GUDID UDI-DI 00852553007148 listed 29 Nov 2016 Listed

1. 29 Mar 1990 Cleared FDA 510(k) K901113
2. 29 Nov 2016 Listed FDA GUDID 00852553007148

Trade name

Matrix Plus Chemistry Reference Kit

Generic name

Multiple clinical chemistry protein IVD, calibrator

Model / reference

9500

Primary DI / UDI-DI

00852553007148

510(k) Number

K901113 ↗

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

Category: Multiple clinical chemistry protein IVD, calibrator

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• Alinity 04V3701 by Abbott Ireland Diagnostics
• FLAME PHOTOMETER CALIBRATION STANDARDS by Fisher Scientific Co., LLC
• DUPONT ACA MAGNESIUM CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc.

• Lipoprotein Verifier Kit 9570

  Class II

  FDA 510(k) K924904 Active Cleared 13 Jan 1993 GUDID on market

• Enzymer Verifier Kit 9430

  Class I

  FDA 510(k) K880266 Active Cleared 18 Feb 1988 GUDID on market

• Total Protein/Albumin Standard Kit, Level F 9466

  Class II

  FDA 510(k) K882116 Active Cleared 24 Jun 1988 GUDID on market

• HDL Cholesterol Verifier Kit 9560

  Class II

  FDA 510(k) K924904 Active Cleared 13 Jan 1993 GUDID on market

See all devices from Verichem Laboratories, Inc. →