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ORGENTEC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30032320423003232042ORGENTEC DIAGNOSTIKA GMBH1N2026-01-01CARL-ZEISS-STRASSE 49-51 MAINZ Rhineland-Palatinate DE 55129

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04260157080188ANTI-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.+49061319258BARBARA.MANSI@ORGENTEC.COM
04260157080232RHEUMATOID 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.+49061319258BARBARA.MANSI@ORGENTEC.COM
04260157080249RHEUMATOID 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.+49061319258BARBARA.MANSI@ORGENTEC.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
161281347200117K974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAMOB1998-02-17
161281893852001K974701ORGENTEC ANTI-MPO (P-ANCA) ELISAMOB1998-02-17
161281412821085K962926ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYMID1996-10-10
161281587823156K962469ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYMID1996-09-09
161281783531495K962062ORGENTEC ANTI-SM ELISALJM1996-11-18
161281099265388K962057ORGENTEC ANTI-RNP/SM ELISALJM1996-11-18
161282056448791K962055ORGENTEC ANTI-SCL 70 ELISALJM1996-11-15
161281078562053K962054ORGENTEC ANTI-SS-A(RO) ELISALJM1996-11-15
161281438045969K962053ORGENTEC ANTI-JO-1 ELISALJM1996-11-15
161281965465057K962052ORGENTEC ABTI-SS-BB(LA) ELISALJM1996-11-15
161281660640882K955449ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAYMID1996-05-23
161281094409666K955134ORGENTEC ENASCREEN ELISA ASSAYLLL1996-03-20
161281888527733K953671ORGEN TEC ANTI-DSDNA ELISA ASSAYLRM1995-11-09
161281994170482K952130ORGENTEC ANTI-TG ELISAJZO1995-06-20
161281918207534K952129ORGENTEC ANTI-TPO ELISAJZO1995-06-20
161281105081402K100499ORGENTEC RHEUMATOID FACTOR EIADHR2010-10-27
161281634372137K092399ANTI-MUTATED CITRULLINATED VIMENTIN EIAOQZ2010-07-01
161281557494018K030929ANA DETECTLJM2003-05-02
161281747818914

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJM72003-05-02
MID31996-10-10
MOB21998-02-17
JZO21995-06-20
DHR12010-10-27
OQZ12010-07-01
LLL11996-03-20
LRM11995-11-09

PMN#

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.

ORGENTEC Diagnostika GmbH

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.

ORGENTEC Diagnostika GmbH

2023-12-14