AccessGUDID - DEVICE: Atellica IM Syph (00630414599885)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM Syph
Version or Model: 10995675
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995675
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414599885
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Syphillis (Syph) Atellica IM - RGT 200T

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):	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?
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
LIP	ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112343	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
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend.
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: d9302bed-b7e8-45b0-881a-c9a8f006dd98
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: February 06, 2018