AccessGUDID - DEVICE: Express HIV-1 Test System (M769HIVEXPRESS201)

GUDID

Device Identifier (DI) Information

Brand Name: Express HIV-1 Test System
Version or Model: 20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Home Access Health Corporation

Primary DI Number: M769HIVEXPRESS201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 848511283 *Terms of Use

Device Description: The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing.

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):	Yes
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?
38092	Capillary blood collection kit, home-use	A collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVZ	System,Test,Home,Hiv-1

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP950002	0

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: 74914157-a27c-4b4e-b8cd-f60b12da3d0a
Public Version Date: November 23, 2021
Public Version Number: 5
DI Record Publish Date: September 03, 2015