PolyTiter ANA-CAL

Trade name

PolyTiter

Generic name

Multiple antinuclear antibody (ANA) IVD, calibrator

Model / reference

ANA-CAL

Primary DI / UDI-DI

00855574005360

FDA product code

DHN

GMDN term

Multiple antinuclear antibody (ANA) IVD, calibrator

Device class

Class II

Regulation number

866.5100

GUDID distribution status

Not in Commercial Distribution

Other devices filed under FDA product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control).

• CRITHIDNA ANTI-DNA TEST KIT by Antibodies, Inc.
• HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM by Tissue Culture Biotec, Inc.
• FLOUROSET IMMUNOFLUORESCENT ANTIBODY by Immulok, Inc.
• TEST KIT, IIF-ANA by Medica Corp.
• FIAX TEST FOR ANTI-RUBELLA ANTIBODY by Idt, A Division of Whittaker M.A. Bioproducts
• MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL by Meloy Laboratories, Inc.
• RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON by E.I. Dupont DE Nemours & Co., Inc.
• HYPERION VISIQUANT ANA TEST KIT by Hyperion, Inc.
• AUTOANTIBODY REAGENTS, AFT SYSTEM II by Calbiochem-Behring Corp.
• ANA TEST by Gull Laboratories, Inc.

• C-Reactive Protein (Crp) Agglutination Latex Kit

  Class II

  FDA 510(k) K962049 Active Cleared 18 Dec 1996

• Poly stat STS25

  Class I

  FDA 510(k) K040708 Active Cleared 22 Nov 2004 GUDID on market

• Poly stat HCG-POC

  Class I

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

• Poly stat FLU25

  Class I

  FDA 510(k) K132465 Active Cleared 9 Sep 2013 GUDID on market

See all devices from Polymedco, Inc. →