AccessGUDID - DEVICE: Serim® PeriScreen™ Test Strips (M17451221)

GUDID

Device Identifier (DI) Information

Brand Name: Serim® PeriScreen™ Test Strips
Version or Model: 5122
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5122
Company Name: SERIM RESEARCH CORPORATION

Primary DI Number: M17451221
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 605151018 *Terms of Use

Device Description: Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.

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?
33738	Leukocyte esterase IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of leukocyte esterase in a clinical specimen within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJX	Test, Urine Leukocyte

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000578	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 15 and 30 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b2820dbd-6d26-4679-ad2d-0a8b23da23ed
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: September 08, 2016