Atlas FDA

BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k) clearance K090409 · decided 2009-05-08

Clearance details

K-number
K090409
Device name
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Applicant
Bio-Rad Laboratories
Decision
Substantially Equivalent
Date received
2009-02-18
Decision date
2009-05-08
Days to decision
79 days
Clearance type
Traditional
Product code
MXJ
Device class
2
Regulation number
866.3305
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Redmond, WA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls (K213987)Biokit, S.A.2023-09-20
Elecsys HSV-1 IgG (08948844160) (K220923)Roche Diagnostics2022-10-12
ADVIA Centaur Herpes-1 IgG (K181333)Biokit, S.A.2018-08-23
SeraQuest Herpes Type 1 Specific IgG (K162276)Quest International, Inc.2016-10-01
Theranos Herpes Simplex Virus-1 IgG Assay (K143236)Theranos, Inc.2015-07-02
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST (K131334)Gold Standard Diagnostics2014-02-28
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (K120625)Roche Diagnostics2012-07-25
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT (K120959)Bio-Rad Laboratories2012-06-22
ZEUS ELISA HSV GC-I IGG TEST SYSTEM (K103363)Zeus Scientific, Inc.2011-04-26
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG (K081685)DiaSorin, Inc.2008-11-18
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM (K072178)Zeus Scientific, Inc.2008-05-30
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G (K071511)Focus Diagnostics, Inc.2007-10-05

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MONOLISA ANTI-HBS EIA (P050048/S010)Bio-Rad Laboratories2025-04-18
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S009)Bio-Rad Laboratories2013-12-12
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S008)Bio-Rad Laboratories2012-11-13
BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S007)Bio-Rad Laboratories2012-11-13
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S004)Bio-Rad Laboratories2011-04-25
MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S005)Bio-Rad Laboratories2010-11-23
BIO-RAD MONOLISA ANTI -HBS EIA (P050048/S006)Bio-Rad Laboratories2010-09-27
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S002)Bio-Rad Laboratories2010-03-12