AccessGUDID - DEVICE: IMMULITE®/IMMULITE® 1000 Systems RHC Turbo HCG (00630414964898)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE®/IMMULITE® 1000 Systems RHC Turbo HCG
Version or Model: 10381169
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LSKCG1
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414964898
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: HCG Total - 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?
54211	Total human chorionic gonadotropin 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 human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen using a chemiluminescent immunoassay method. It is used to aid detection of pregnancy, or as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DHA	SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K994085	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: f5dbc0a0-9d94-4857-be8f-e34d56339cbe
Public Version Date: January 08, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2016