AccessGUDID - DEVICE: IMMULITE® Systems SYP CONTROL Syphilis Screen (00630414976686)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® Systems SYP CONTROL Syphilis Screen
Version or Model: 10469593
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LSYCM
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414976686
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: Syphillis - IMMULITE - CTL - 2x6mL

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?
32449	Treponema pallidum reagin antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen.	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 [?]
K091361	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: 5b60ff60-9e43-4e94-802d-a967b1926f4e
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016