AccessGUDID - DEVICE: ABBOTT PRISM (00380740038403)

GUDID

Device Identifier (DI) Information

Brand Name: ABBOTT PRISM
Version or Model: 3E60-10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 03E6010
Company Name: ABBOTT LABORATORIES

Primary DI Number: 00380740038403
Issuing Agency: GS1
Commercial Distribution End Date: March 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 079226220 *Terms of Use

Device Description: ABBOTT PRISM Run Control Kit

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:	Yes
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?
42652	Multiple blood-borne virus antigen/antibody IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of antigens and/or antibodies from one or multiple blood-borne viruses, in a clinical specimen. Viruses intended to be detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus and human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: b6fc24d8-ede0-4a9a-982b-908eafbff772
Public Version Date: June 21, 2023
Public Version Number: 5
DI Record Publish Date: January 31, 2015