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Panels › Microbiology › Product code LIP · Class 2

Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

Regulation 866.3830

0510(k)s in 12 months (35 all time)
2recalls in 12 months (18 all time)
16recalls that name a 510(k)
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Top companies in LIP

DateFirm and productCodeLinked 510(k)
Aug 14, 2026Siemens Healthcare Diagnostics Products Ltd.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Open, Classified
LIPK091361
Aug 14, 2026Siemens Healthcare Diagnostics Products Ltd.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Open, Classified
LIPK091361
Apr 14, 2022Bio-Rad Laboratories, Inc.
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Open, Classified
LIPNone listed
Feb 8, 2022Bio-Rad Laboratories, Inc.
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Open, Classified
LIPK170413
Feb 8, 2022Bio-Rad Laboratories, Inc.
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Open, Classified
LIPK170413
Sep 17, 2021Bio-Rad Laboratories, Inc.
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RP
Open, Classified
LIPK170413
Sep 17, 2021Bio-Rad Laboratories, Inc.
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (I
Open, Classified
LIPK170413
Apr 21, 2021Siemens Healthcare Diagnostics, Inc
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Cent
Open, Classified
LIPK112343
Apr 21, 2020Bio-Rad Laboratories, Inc.
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponem
Open, Classified
LIPK170413
Dec 16, 2014Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for th
Terminated
LIPK904524
Dec 26, 2013Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponem
Terminated
LIPNone listed
Aug 20, 2012Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitati
Terminated
LIPK112343
Nov 23, 2010Bio-Rad Laboratories
BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPle
Terminated
LIPK063866
Jun 11, 2008Bio-Rad Laboratories
BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is a multiplex flow immunoassay intended for the qualitative d
Terminated
LIPK063866
Nov 9, 2007Bio-Rad Labroatories Inc.
BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD
Terminated
LIPK063866
Apr 28, 2005Diasorin Inc.
Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat
Terminated
LIPK001552
Dec 17, 2004Diamedix Corporation
The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be u
Terminated
LIPK001552
Jul 20, 2004Diamedix Corporation
Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 3
Terminated
LIPK001552

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