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THERADIAG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039352533003935253THERADIAG1N2026-01-0114 rue AMBROISE CROIZAT CS 90136 CROISSY BEAUBOURG MARNE LA VALLEE CEDEX 2 Seine-et-Marne FR 77435

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
03760170782003FIDIS - Simultaneous detection kit of 10 antibodies: dsDNA, SSA 60, TRIM 21 (SSA 52), SSB, Sm, SmRNP, Scl70, Jo1, CENP-B, ribosomes0164621012support@theradiag.com
03760170782027IMMUNO-TROL - Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: Anti-double stranded deoxyribonucleic acid– Level 1 DNA* ,Anti-Sjögren’s Syndrom antigen A - 60 kDa. SS-A 60, Anti-Sjögren’s Syndrom antigen A - 52 kDa SS-A 52 ,Anti-Sjögren’s Syndrom antigen B SS-B, Anti-Smith antigen Sm ,Anti-Smith and ribonucleoproteins antigens Sm/RNP ,Anti- U1 ribonucleoproteins antigen U1RNP .0164621012support@theradiag.com
03760170782034IMMUNO-TROL - Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: Anti-double stranded deoxyribonucleic acid – Level 2 DNA* ,Anti-ribosomal antigen Ribo ,Anti-centromere antigen CENP-B ,Anti-histidyl tRNA synthetase antigen Jo-1 ,Anti-scleroderma antigen - 70 kDA Scl-70 .0164621012support@theradiag.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
638251601442959K053653FIDIS CONNECTIVE 10, MODEL MX006LLL2006-03-13
638251993898598K053012FIDIS VASCULITIS, MODEL MX007MOB2006-03-02
638251128851184
638251850284534

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLL22006-03-13
MOB22006-03-02

GUDID#

IMMUNO-TROL - Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: Anti-double stranded deoxyribonucleic acid– Level 1 DNA* ,Anti-Sjögren’s Syndrom antigen A - 60 kDa. SS-A 60, Anti-Sjögren’s Syndrom antigen A - 52 kDa SS-A 52 ,Anti-Sjögren’s Syndrom antigen B SS-B, Anti-Smith antigen Sm ,Anti-Smith and ribonucleoproteins antigens Sm/RNP ,Anti- U1 ribonucleoproteins antigen U1RNP .

THERADIAG SA

2018-09-24