AccessGUDID - DEVICE: Dimension® clinical chemistry system TPSA Flex® reagent cartridge (00842768013874)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® clinical chemistry system TPSA Flex® reagent cartridge
Version or Model: 10444889
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RF451
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768013874
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent cartridge 120 Test

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?
54664	Total prostate specific antigen (tPSA) 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 total prostate specific antigen (tPSA) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MTF	Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000021	001
P000021	002
P000021	003
P000021	004
P000021	006
P000021	010
P000021	012
P000021	014
P000021	015
P000021	017
P000021	019
P000021	023

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: eaf81e21-3e8e-455f-b709-738d6f713875
Public Version Date: November 18, 2021
Public Version Number: 8
DI Record Publish Date: September 24, 2014