AccessGUDID - DEVICE: OraQuick In Home HIV Test (00608337103403)

GUDID

Device Identifier (DI) Information

Brand Name: OraQuick In Home HIV Test
Version or Model: 1001-0340
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orasure Technologies, Inc.

Primary DI Number: 00608337103403
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):	No
Over the Counter (OTC):	Yes
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
MZF	Test, Hiv Detection

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 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c176c94-2ea1-4168-bfe9-2767348f799c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 05, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10608337103400	6	00608337103403	In Commercial Distribution	carton
00608337000948	4	00608337103403	In Commercial Distribution	display
20608337103407	4	00608337103403	In Commercial Distribution	display