AccessGUDID - DEVICE: Elecsys Syphilis (07613336183083)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys Syphilis
Version or Model: 09015051162
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09015051162
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336183083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 315028860 *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:	No
Prescription Use (Rx):	Yes
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?
59863	Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a chemiluminescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYR	Test, donor, syphilis, antigens, treponemal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK230839	0

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 794f1ba2-00ee-4475-b949-55894e46b5c1
Public Version Date: October 13, 2023
Public Version Number: 1
DI Record Publish Date: October 05, 2023