AccessGUDID - DEVICE: RealTime (00884999023918)

GUDID

Device Identifier (DI) Information

Brand Name: RealTime
Version or Model: 06L18-66
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06L18-66
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999023918
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: Abbott RealTime HIV-1 Amplification Including Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HIV-1 assay List Number 06L18

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
MZF	Test, hiv detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP060002	13
BP060002	14
BP060002	16
BP060002	18
BP060002	21
BP060002	22
BP060002	25
BP060002	26
BP060002	27
BP060002	28
BP060002	29
BP060002	36
BP060002	37
BP060002	38
BP060002	42
BP060002	45
BP060002	46
BP060002	48
BP060002	6
BP060002	8
BP060002	9

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: ebd72981-ad17-4186-b589-1b3ee2e41dbd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 01, 2016