AccessGUDID - DEVICE: QMedix™ (00850054026651)

GUDID

Device Identifier (DI) Information

Brand Name: QMedix™
Version or Model: DACD113029-1-19
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 113029-1-19
Company Name: Diagnostic Automation, Inc.

Primary DI Number: 00850054026651
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878252071 *Terms of Use

Device Description: QMedix™ hCG Combo Urine/Serum RapiCard™ InstaTest is used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG),

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:	Yes
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?
33819	Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)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 within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JHI	Visual, Pregnancy Hcg, Prescription Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: 25 TESTS

Device Record Status

Public Device Record Key: 0659a14b-9aba-40d1-b65a-eba02eaa2285
Public Version Date: July 03, 2024
Public Version Number: 1
DI Record Publish Date: June 25, 2024