AccessGUDID - DEVICE: AESKULISA tTg-G New Generation (04250289503136)

GUDID

Device Identifier (DI) Information

Brand Name: AESKULISA tTg-G New Generation
Version or Model: 7504US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7504US
Company Name: Aesku.Diagnostics GmbH & Co. KG

Primary DI Number: 04250289503136
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341714388 *Terms of Use

Device Description: The AESKULISA tTg-G New Generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgG antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum.

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?
55223	Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to tissue transglutaminase (anti-tTG) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042644	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: d84f4b02-1240-4f27-909b-e66bf1f6e1d4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 17, 2017