IMMUNO-TROL HM 061US-2X05

GUDID 03760170782034

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 .

THERADIAG SA

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control
Primary Device ID03760170782034
NIH Device Record Keye3590496-d50d-4c84-b9e7-f717ee893072
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMMUNO-TROL
Version Model NumberCONNECTIVE 2
Catalog NumberHM 061US-2X05
Company DUNS391123478
Company NameTHERADIAG SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com
Phone0164621012
Emailsupport@theradiag.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103760170782034 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-03-08
Device Publish Date2018-09-24

On-Brand Devices [IMMUNO-TROL]

03760170782102Reagent, prepared from human serum, intended for use as an unassayed precision control for deter
03760170782072Reagent, prepared from human serum, intended for use as an unassayed precision control for deter
03760170782034Reagent, prepared from human serum, intended for use as an unassayed precision control for deter
03760170782027Reagent, prepared from human serum, intended for use as an unassayed precision control for deter

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