AccessGUDID - DEVICE: Alere Determine HIV-1/2 Ag/Ab Combo Controls (07290015003759)

GUDID

Device Identifier (DI) Information

Brand Name: Alere Determine HIV-1/2 Ag/Ab Combo Controls
Version or Model: Alere Determine HIV-1/2 Ag/Ab Combo Cont
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7D2628
Company Name: Orgenics Ltd

Primary DI Number: 07290015003759
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600022628 *Terms of Use

Device Description: Contents HIV-1 Reactive Control, 1.5 mL HIV-2 Reactive Control, 1.5 mL P24 Antigen Control, 1.5 mL HIV Nonreactive Control, 1.5 mL

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):	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?
48449	HIV1/HIV2 antigen/antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d433d2b3-af8a-44c7-a039-d7c6c5b4f5be
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2014