AccessGUDID - DEVICE: Atellica IM CHIV (00630414600390)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM CHIV
Version or Model: 10995459
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995459
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414600390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: CHIV - Atellica IM - RGT - 100T

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?
48446	HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials 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, using an chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZF	Test, HIV detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK241075	000
BP140103	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
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: 40766460-c4bc-48b2-9d62-ef4ed1d57d1e
Public Version Date: April 18, 2025
Public Version Number: 6
DI Record Publish Date: December 21, 2018