AccessGUDID - DEVICE: Atellica™ IM HBcT (00630414599205)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica™ IM HBcT
Version or Model: 10995597
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995597
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414599205
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: HBC Total Ab (HBcT) - Atellica IM - RGT - 200T

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?
48304	Hepatitis B virus core total 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 total antibodies to the Hepatitis B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOM	Test, hepatitis b (b core, be antigen, be antibody, b core igm)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P040004	002
P040004	003
P040004	004
P040004	005
P040004	006
P040004	007
P040004	008
P040004	009
P040004	010
P040004	011
P040004	012
P040004	013
P040004	014

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: 1effa7bf-ca1d-4a3a-96ab-d18afb3df570
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: October 16, 2018