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)
Top companies in LIP
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad Laboratories | 3 | 8 |
| Mercia Diagnostics , Ltd. | 4 | 0 |
| Siemens Healthcare Diagnostics | 2 | 2 |
| DiaSorin, Inc. | 2 | 1 |
| Clark Laboratories, Inc. (dba,Trinity Biotech USA) | 0 | 2 |
| Diagnostic Chemicals, Ltd. (Usa) | 2 | 0 |
| Diamedix Corporation | 0 | 2 |
| Ortho Diagnostic Systems, Inc. | 2 | 0 |
| Phoenix Biotech Corp. | 2 | 0 |
| Pyramid Biological Corp. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Siemens Healthcare Diagnostics Products Ltd. Siemens Healthineers
Immulite 2000 Systems SYP Syphilis Screen
REF(s):L2kSY2/10489085; L2KSY6/10488319
IVD, RxOnly Open, Classified |
LIP | K091361 |
| Aug 14, 2026 | Siemens Healthcare Diagnostics Products Ltd. Siemens Healthineers
Immulite 2000 Systems SYP Syphilis Screen
REF:L2KSY2(D)/10471981
IVD, RxOnly Open, Classified |
LIP | K091361 |
| Apr 14, 2022 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack Open, Classified |
LIP | None listed |
| Feb 8, 2022 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL Open, Classified |
LIP | K170413 |
| Feb 8, 2022 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack Open, Classified |
LIP | K170413 |
| Sep 17, 2021 | Bio-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 |
LIP | K170413 |
| Sep 17, 2021 | Bio-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 |
LIP | K170413 |
| Apr 21, 2021 | Siemens 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 |
LIP | K112343 |
| Apr 21, 2020 | Bio-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 |
LIP | K170413 |
| Dec 16, 2014 | Clark 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 |
LIP | K904524 |
| Dec 26, 2013 | Clark 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 |
LIP | None listed |
| Aug 20, 2012 | Siemens 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 |
LIP | K112343 |
| Nov 23, 2010 | Bio-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 |
LIP | K063866 |
| Jun 11, 2008 | Bio-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 |
LIP | K063866 |
| Nov 9, 2007 | Bio-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 |
LIP | K063866 |
| Apr 28, 2005 | Diasorin 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 |
LIP | K001552 |
| Dec 17, 2004 | Diamedix 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 |
LIP | K001552 |
| Jul 20, 2004 | Diamedix 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 |
LIP | K001552 |
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