AccessGUDID - DEVICE: Serim® PyloriTek® Test Kit (M1745140K1)

GUDID

Device Identifier (DI) Information

Brand Name: Serim® PyloriTek® Test Kit
Version or Model: 05140K
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05140K
Company Name: SERIM RESEARCH CORPORATION

Primary DI Number: M1745140K1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 605151018 *Terms of Use

Device Description: The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.

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?
52787	Helicobacter pylori urease IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen, using a chromogenic test method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYR	Helicobacter Pylori

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953632	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 7 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: b3f89921-9db5-4b95-bfa5-a0baba6fd881
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016