AccessGUDID - DEVICE: OraQuick Advance Rapid HIV 1/2 Antibody Test (00608337000016)

GUDID

Device Identifier (DI) Information

Brand Name: OraQuick Advance Rapid HIV 1/2 Antibody Test
Version or Model: 3001-1197
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orasure Technologies, Inc.

Primary DI Number: 00608337000016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 114152184 *Terms of Use

Device Description: No description.

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:	No
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?
48454	HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses and may be available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MTL	Monitor,Test,Hiv-1

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP010047	006
BP010047	007
BP010047	008
BP010047	010
BP010047	011
BP010047	012
BP010047	013
BP010047	015
BP010047	016
BP010047	017
BP010047	019
BP010047	022
BP010047	023
BP010047	025
BP010047	026
BP010047	028
BP010047	029
BP010047	030
BP010047	031
BP010047	032
BP010047	034
BP010047	035
BP010047	036
BP010047	039
BP010047	040
BP010047	041
BP010047	042
BP010047	043
BP010047	044
BP010047	045
BP010047	046
BP010047	047
BP010047	048
BP010047	049
BP010047	050
BP010047	051
BP010047	052
BP010047	053
BP010047	054

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 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6678785-c442-4d19-bfc7-a95495627ef9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 05, 2014