AccessGUDID - DEVICE: Atellica IM aHCV 200T (00630414278742)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM aHCV 200T
Version or Model: 11203473
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11203473
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414278742
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Atellica IM aHCV 200T Kit

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:	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?
48366	Hepatitis C virus total antibody IVD, kit, chemiluminescent assay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis C virus in a clinical specimen, using a chemiluminescent immunoassay method.	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 [?]
P030056	002
P030056	003
P030056	004
P030056	005
P030056	006
P030056	007
P030056	008
P030056	009
P030056	010
P030056	011
P030056	013

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
Handling 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: 070c5f88-bb73-487b-9f34-32a1c1123867
Public Version Date: December 22, 2021
Public Version Number: 4
DI Record Publish Date: November 01, 2018