AccessGUDID - DEVICE: RealTime (00884999034266)

GUDID

Device Identifier (DI) Information

Brand Name: RealTime
Version or Model: 08L21-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08L21-01
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999034266
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM, Version 1.0

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):	Yes
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?
43472	Laboratory instrument/analyser application software IVD	An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBF	Assay, genotyping, hepatitis c virus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P120012	001
P120012	002
P120012	003
P120012	004
P120012	005
P120012	006
P120012	007
P120012	009
P120012	010
P120012	011
P120012	012
P120012	013

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0bf57a52-dde5-431d-967d-65df496ec6b2
Public Version Date: March 22, 2022
Public Version Number: 4
DI Record Publish Date: November 20, 2014