AccessGUDID - DEVICE: AcroMetrix BB NAT HCV Positive Control (00884883005921)

GUDID

Device Identifier (DI) Information

Brand Name: AcroMetrix BB NAT HCV Positive Control
Version or Model: 963601
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Microgenics Corporation

Primary DI Number: 00884883005921
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122153799 *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):	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?
48384	Hepatitis C virus antibody/antigen 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 Hepatitis C virus antigens and antibodies to Hepatitis C virus antigens in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYZ	Kit,Test(Donors),For Bloodborne Pathogen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK040060	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: f8b423d8-add2-49d0-883b-98e027a6b7e8
Public Version Date: October 18, 2023
Public Version Number: 4
DI Record Publish Date: September 22, 2016