AccessGUDID - DEVICE: IMMULITE®/IMMULITE®1000 Systems aHB Anti-HBs (00630414970998)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE®/IMMULITE®1000 Systems aHB Anti-HBs
Version or Model: 10372452
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LKAH1(D)
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414970998
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: aHB Anti-HBs Kit 100 Test

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):	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?
48316	Hepatitis B virus surface 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 surface 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 [?]
P010052	001
P010052	004
P010052	005
P010052	007
P010052	008
P010052	012

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
Special Storage Condition, Specify: Protect from Light
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ee42abf-d40e-4c2a-9257-81584ddea0e5
Public Version Date: November 18, 2021
Public Version Number: 8
DI Record Publish Date: September 24, 2014