Calibration Serum Level 2 CA1400

Trade name

Calibration Serum Level 2

Generic name

Multiple-type clinical chemistry analyte profile IVD, calibrator

Model / Ref / Catalog

CA1400

Primary DI / UDI-DI

00817439020338

FDA product code

JIX

GMDN term

Multiple-type clinical chemistry analyte profile IVD, calibrator

Device class

Class II

Regulation number

862.1150

GUDID distribution status

Not in Commercial Distribution

Other devices filed under FDA product code JIX (Calibrator, Multi-Analyte Mixture).

• KM-KAL L2 by Kmn Products, Inc.
• MATRIX PLUS MULTI-CALIBRATOR KIT by VERICHEM LABORATORIES, INC.
• Alinity 08P7201 by Abbott
• CEDIA CORE TDM MULTI-CAL by Boehringer Mannheim Corp.
• DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM by E.I. Dupont DE Nemours & Co., Inc.
• Dimension Vista T4/TU CAL 11319105 KC165 by Siemens Healthcare Diagnostics Inc.
• HITACHI 705 CALIBRATOR by Boehringer Mannheim Corp.
• CIBA CORNING ACS FOLATE IMMUNOASSAY by Ciba Corning Diagnostics Corp.
• SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 by Sigma Chemical Co.
• Dimension Vista® LOCI 8 CAL 10488192 KC646 by Siemens Healthcare Diagnostics Inc.

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  Class I

  FDA 510(k) K921206 Active Cleared 29 Apr 1992 GUDID on market

• MedTest DX HCG Control Set HCG-CTL

  Class I

  FDA 510(k) K921206 Active Cleared 29 Apr 1992 GUDID on market

• Alt / BS480 ALT480

  Class I

  GUDID on market

• MedTest DX Elevated HCG Control Vial Label - A HCGCTLA

  Class I

  FDA 510(k) K921206 Active Cleared 29 Apr 1992 GUDID on market

See all devices from Medtest DX →