AccessGUDID - DEVICE: AESKULISA® Cenp-B (04250289500548)

GUDID

Device Identifier (DI) Information

Brand Name: AESKULISA® Cenp-B
Version or Model: 3112
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aesku.Diagnostics GmbH & Co. KG

Primary DI Number: 04250289500548
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341714388 *Terms of Use

Device Description: AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome.

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:	Yes
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?
54889	Centromere protein antibody (anti-CENP) 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 centromere protein (anti-CENP) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 1ac7e6c1-0656-4a78-9146-f3bb58a47c80
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 27, 2016