FDA.reportPublic FDA data

IMMUNO-TROL

Primary DI
03760170782034
Brand
IMMUNO-TROL
Company
THERADIAG SA
Model
CONNECTIVE 2
Catalog number
HM 061US-2X05
Device description
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 .
Published
2018-09-24
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
03760170782034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760170782034037601707820343760170782034

GMDN Terms#

Term, Definition table
TermDefinition
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, controlA material which is used to verify the performance of an assay 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.

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
Premarket exempt
true
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
03760170782003FIDISConnective 10MX 5062016-12-01
03760170782027IMMUNO-TROLCONNECTIVE 1HM 060US-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