AccessGUDID - DEVICE: MAS anti-HBs Positive Control – For use with Siemens Assays (00884883007383)

GUDID

Device Identifier (DI) Information

Brand Name: MAS anti-HBs Positive Control – For use with Siemens Assays
Version or Model: 10027482-U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Microgenics Corporation

Primary DI Number: 00884883007383
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):	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?
48291	Hepatitis B virus antigen/antibody marker 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 one or multiple Hepatitis B virus antigen and/or antibody markers in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHQ	Multi-Analyte Controls Unassayed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 18f55a84-2bb1-4d94-a0fd-8a31db2f638c
Public Version Date: May 13, 2021
Public Version Number: 1
DI Record Publish Date: May 05, 2021