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510(k) K060641

PLATELIA ASPERGILLUS EIA, MODEL 62793 by Bio-Rad — Product Code NOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2006
Date Received
March 10, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Galactomannan, Aspergillus Spp.
Device Class
Class I
Regulation Number
866.3040
Review Panel
MI
Submission Type

The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.

Other clearances by Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (November 9, 2005)

Other clearances for product code NOM

  • K243496 — MycoMEIA Aspergillus Assay (August 1, 2025)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K023857 — PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 (May 16, 2003)