AccessGUDID - DEVICE: IMMULITE®/IMMULITE® 1000 Systems ALB Albumin (00630414964096)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE®/IMMULITE® 1000 Systems ALB Albumin
Version or Model: 10381385
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LKHA1
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414964096
Issuing Agency: GS1
Commercial Distribution End Date: September 16, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: Albumin - IMMULITE - RGT - 100 Tests

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?
53598	Albumin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis and monitoring of diseases affecting protein metabolism (e.g., liver disease, kidney disease, severe malnutrition, malabsorption, burns).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DFJ	ALBUMIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022603	000

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a1f6d7e-e800-4bdb-b76b-26c767287e8c
Public Version Date: October 16, 2025
Public Version Number: 8
DI Record Publish Date: September 24, 2016