AccessGUDID - DEVICE: ADVIA Centaur® AFP (00630414177335)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® AFP
Version or Model: 10309980
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110764
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414177335
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Alpha-Fetoprotein (AFP) Assay Kit (5-pack) 500T

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?
58348	Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P930036	001
P930036	002
P930036	003
P930036	005

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: dc8e21ce-19c9-4e8e-b840-609a6bacb6fd
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2014