AccessGUDID - DEVICE: RealTime (00884999036444)

GUDID

Device Identifier (DI) Information

Brand Name: RealTime
Version or Model: 08L21-66
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08L21-66
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999036444
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV Genotype II Assay

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):	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?
61119	DNA anti-contamination enzyme reagent IVD	A substance or reactant intended to be used as a hydrolyzing enzyme in a molecular assay to prevent contamination of the resulting deoxyribonucleic acid (DNA) amplicon, by preventing unintentional carry over of amplification products from a previous assay, in the analysis of a clinical laboratory specimen, using a polymerase chain reaction (PCR) technique.	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
P120012	014

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 -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 12de4e1f-9738-410b-a2d6-d10b89e3bd31
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 20, 2014