AccessGUDID - DEVICE: EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) (04049016124894)

GUDID

Device Identifier (DI) Information

Brand Name: EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)
Version or Model: DL 1300-6401-8 G
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EUROIMMUN Medizinische Labordiagnostika AG

Primary DI Number: 04049016124894
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 322209263 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54830	Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with liver disease in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at liver-kidney microsome 1 protein (anti-LKM1), smooth muscle (anti-SMA), F-Actin, soluble liver antigen (SLA), Sp-100 protein, glycoprotein-210 (gp210), lamin B receptor (LBR) and also liver cytosol specific antibody type 1 (anti-LC1) and/or antimitochondrial antibodies (AMA).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUM	Autoantibodies, Nuclear Body Protein, Sp100
NRI	Autoantibodies, Nuclear Pore Glycoprotein Gp210
NIY	Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
NBS	Autoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1)
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113439	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a4e9551c-ffee-42b1-a8a8-a84f92338ece
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016