AccessGUDID - DEVICE: ABBOTT PRISM (00380740063016)

GUDID

Device Identifier (DI) Information

Brand Name: ABBOTT PRISM
Version or Model: 6E50-68
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 06E5068
Company Name: ABBOTT LABORATORIES

Primary DI Number: 00380740063016
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 HTLV-I/HTLV-II Assay 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?
48524	Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2) in a clinical specimen, using a chemiluminescent immunoassay method.	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: 0880492c-e30b-4008-81fd-a79a48fe77ef
Public Version Date: June 21, 2023
Public Version Number: 7
DI Record Publish Date: January 31, 2015