orgentec.comORGENTEC RHEUMATOID FACTOR EIA
ORGENTEC DIAGNOSTIKA GMBH
ORGENTEC DIAGNOSTIKA GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003232042 | 3003232042 | ORGENTEC DIAGNOSTIKA GMBH | 1 | N | 2026-01-01 | CARL-ZEISS-STRASSE 49-51 MAINZ Rhineland-Palatinate DE 55129 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04260157080010 | ANTI-TG - ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | +49061319258 | BARBARA.MANSI@ORGENTEC.COM |
| 04260157080027 | ANTI-TPO - ANTI-TPO IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROID PEROXIDASE (TPO) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | +49061319258 | BARBARA.MANSI@ORGENTEC.COM |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 16128 | 1347200117 | K974702 | ORGENTEC ANTI-PR3 (C-ANCA) ELISA | MOB | 1998-02-17 |
| 16128 | 1893852001 | K974701 | ORGENTEC ANTI-MPO (P-ANCA) ELISA | MOB | 1998-02-17 |
| 16128 | 1412821085 | K962926 | ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY | MID | 1996-10-10 |
| 16128 | 1587823156 | K962469 | ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY | MID | 1996-09-09 |
| 16128 | 1783531495 | K962062 | ORGENTEC ANTI-SM ELISA | LJM | 1996-11-18 |
| 16128 | 1099265388 | K962057 | ORGENTEC ANTI-RNP/SM ELISA | LJM | 1996-11-18 |
| 16128 | 2056448791 | K962055 | ORGENTEC ANTI-SCL 70 ELISA | LJM | 1996-11-15 |
| 16128 | 1078562053 | K962054 | ORGENTEC ANTI-SS-A(RO) ELISA | LJM | 1996-11-15 |
| 16128 | 1438045969 | K962053 | ORGENTEC ANTI-JO-1 ELISA | LJM | 1996-11-15 |
| 16128 | 1965465057 | K962052 | ORGENTEC ABTI-SS-BB(LA) ELISA | LJM | 1996-11-15 |
| 16128 | 1660640882 | K955449 | ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY | MID | 1996-05-23 |
| 16128 | 1094409666 | K955134 | ORGENTEC ENASCREEN ELISA ASSAY | LLL | 1996-03-20 |
| 16128 | 1888527733 | K953671 | ORGEN TEC ANTI-DSDNA ELISA ASSAY | LRM | 1995-11-09 |
| 16128 | 1994170482 | K952130 | ORGENTEC ANTI-TG ELISA | JZO | 1995-06-20 |
| 16128 | 1918207534 | K952129 | ORGENTEC ANTI-TPO ELISA | JZO | 1995-06-20 |
| 16128 | 1105081402 | K100499 | ORGENTEC RHEUMATOID FACTOR EIA | DHR | 2010-10-27 |
| 16128 | 1634372137 | K092399 | ANTI-MUTATED CITRULLINATED VIMENTIN EIA | OQZ | 2010-07-01 |
| 16128 | 1557494018 | K030929 | ANA DETECT | LJM | 2003-05-02 |
| 16128 | 1747818914 |
Product Codes Associated With Registrations#
PMN#
ANTI-MUTATED CITRULLINATED VIMENTIN EIA
ORGENTEC DIAGNOSTIKA GMBH
ANA DETECT
ORGENTEC DIAGNOSTIKA GMBH
GUDID#
ANA DETECT - ANA Detect is an ELISA test system for the qualitative measurement of IgG class autoantibodies against SS-A-52 (Ro-52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA, ssDNA, ssDNA, polynucleosomes, mononucleosomes, histone complex, histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-100 and centromere B in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of certain systematic rheumatic diseases.
2016-08-31
Micro-Albumin - Micro-Albumin is a competitive ELISA test system for the quantitative measurement of human albumin in urine. This product is intended for professional in vitro diagnostic use only.The rate of albumin excertion in urine is an important control and prevention parameter for the evaluation of kidney function. If the glomerular filtration process is highly active, albumin excretion may be elevated without any kidney damage. Physical stress may also cause microalbuminuria.
2023-12-14
ANTI-TG - ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
2016-08-31
ANTI-TPO - ANTI-TPO IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROID PEROXIDASE (TPO) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
2016-08-31
ENASCREEN - ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUTOANTIBODIES AGAINST EXTRACABLE NUCLEAR ANTIGENS (ena) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGONSTIC USE ONLY.
2016-08-31
ANTI-SS-A - ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-A (52 AND 60kDa) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
2016-08-31
ANTI-SS-B - ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
2016-08-31
ANTI-SM - ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SM IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
2016-08-31
ANTI-RPN/SM - ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST RNP/SM IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
2016-08-31
ANTI-SCI-70 - ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SCL-70 IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PRFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
2016-08-31
ANTI-JO-1 - ANTI-JO-1 IS AN EILSA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST JO-1 IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
2016-08-31
ANTI-CARDIOLIPIN IgG/IgM - Anti-Cardiolipin IgG/IgM is an ELISA test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
2016-08-31
ANTI-CARDIOLIPIN IgA - Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
2016-08-31
ANTI-CARDIOLIPIN SCREEN - Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
2016-08-31
ANTI-PR3 (cANCA) - Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
2016-08-31
ANTI-MPO (pANCA) - Anti-MPO is an ELISA test system for the quantitative measurement of IgG class autoantibodies against myeloperoxidase (MPO) in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
2016-08-31
RHEUMATOID FACTOR IgA - Rheumatoid Factor IgA is an ELISA test system for the quantitative measurement of IgA class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.
2016-08-31
RHEUMATOID FACTOR IgG - Rheumatoid Factor IgG is an ELISA test system for the quantitative measurement of IgG class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.
2016-08-31
RHEUMATOID FACTOR IgM - Rheumatoid Factor IgM is an ELISA test system for the quantitative measurement of IgM class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.
2016-08-31
RHEUMATOID FACTOR TOTAL - Rheumatoid Factor Total is an ELISA test system for the quantitative measurement of IgG, IgM and IgA class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.
2016-08-31
ANTI-dsDNA - Anti-dsDNA is an ELISA test system for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
2016-08-31
ANTI-MCV - Anti-MCV® is an ELISA test system for the qualitative and semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma. This product is intended for professional in vitro diagnostic use as an aid in the diagnosis of Rheumatoid Arthritis in conjuction with other laboratory and clinical findings.
2016-12-08