AccessGUDID - DEVICE: Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge HCG (00842768013850)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge HCG
Version or Model: 10444913
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RF430
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768013850
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Human Chorionic Gonadotropin Flex® reagent cartridge, 120 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:	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?
54210	Total human chorionic gonadotropin 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 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 an enzyme immunoassay (EIA) 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 [?]
K970387	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: 92f12cab-4230-4cb7-ac8c-f2372fdcf606
Public Version Date: July 06, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016