FDA.reportPublic FDA data

FIDIS

Primary DI
03760170782003
Brand
FIDIS
Company
THERADIAG SA
Model
Connective 10
Catalog number
MX 506
Device description
Simultaneous detection kit of 10 antibodies: dsDNA, SSA 60, TRIM 21 (SSA 52), SSB, Sm, SmRNP, Scl70, Jo1, CENP-B, ribosomes
Published
2016-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760170782003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760170782003037601707820033760170782003

GMDN Terms#

Term, Definition table
TermDefinition
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple types of antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen, using a multiplex method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
0164621012support@theradiag.com

Regulatory Flags#

DUNS number
391123478
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760170782072IMMUNO-TROLTHYROHM 065US-2X052018-09-24
03760170782027IMMUNO-TROLCONNECTIVE 1HM 060US-2X052018-09-24
03760170782034IMMUNO-TROLCONNECTIVE 2HM 061US-2X052018-09-24
03760170782102IMMUNO-TROLGASTRITISHM 068US-2X052018-09-24
03760170782041IMMUNO-TROLAPS IgGHM 062US-2X052018-09-24
03760170782058IMMUNO-TROLAPS IgMHM 063US-2X052018-09-24
03760170782065IMMUNO-TROLRHEUMAHM 064US-2X052018-09-24
03760170782089IMMUNO-TROLCYTOHM 066US-2X052018-09-24
03760170782096IMMUNO-TROLVASCULITISHM 067US-2X052018-09-24
03760170782119IMMUNO-TROLCELIAC IgGHM 069US-2X052018-09-24
03760170782126IMMUNO-TROLCELIAC IgAHM 070US-2X052018-09-24
03760170782010FIDISVasculitisMX 5072016-12-01