AccessGUDID - DEVICE: QuickProfile™ HCG Test Strip (M90107RD70010)

GUDID

Device Identifier (DI) Information

Brand Name: QuickProfile™ HCG Test Strip
Version or Model: 07RD7001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07RD7001
Company Name: LUMIQUICK DIAGNOSTICS, INC.

Primary DI Number: M90107RD70010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790175165 *Terms of Use

Device Description: immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-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):	Yes
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?
54216	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.	Obsolete	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981770	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
Handling Environment Temperature: between 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 72 Millimeter

Device Record Status

Public Device Record Key: 297a3292-d061-47df-a530-bc4111d4aa05
Public Version Date: September 24, 2018
Public Version Number: 3
DI Record Publish Date: November 15, 2017