AccessGUDID - DEVICE: Atellica IM AFP (00630414238807)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM AFP
Version or Model: 11202258
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11202258
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414238807
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 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:	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?
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	008
P930036	009

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: 2ac82c75-92cb-4a80-a286-112190c6db86
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: November 14, 2018