AccessGUDID - DEVICE: INNOVANCE Free PS Ag (00842768039522)

GUDID

Device Identifier (DI) Information

Brand Name: INNOVANCE Free PS Ag
Version or Model: 10873458
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OPGL07
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768039522
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer.

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?
60497	Protein S IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of protein S in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGP	TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181525	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: 4788a1ee-1074-4921-a8df-855513354ca3
Public Version Date: February 20, 2024
Public Version Number: 4
DI Record Publish Date: November 15, 2018