AccessGUDID - DEVICE: Atellica™ IM aHCV QC (00630414597874)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica™ IM aHCV QC
Version or Model: 10995457
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995457
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414597874
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: HCV (aHCV) QC Kit - Atellica IM - CLT 2 x 2 x 7.0 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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
41973	Hepatitis C virus total 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 total antibodies to the Hepatitis C virus in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZO	ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

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
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eaa2776f-8b78-4efd-b99a-9a2744375438
Public Version Date: February 16, 2022
Public Version Number: 6
DI Record Publish Date: October 16, 2018