AccessGUDID - DEVICE: Prolex E. coli Non-O157 Identification Kit (10628429001124)

GUDID

Device Identifier (DI) Information

Brand Name: Prolex E. coli Non-O157 Identification Kit
Version or Model: PL.1070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL.1070
Company Name: PRO-LAB, INCORPORATED

Primary DI Number: 10628429001124
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 960418395 *Terms of Use

Device Description: The ProlexTM E. coli Non-O157 Kit provides an easy to use, reliable and affordable way to identify the six most common STEC producing serotypes in North America. The kit uses our blue carboxylated latex particles labelled with antibodies to E. coli O26, E. coli O45, E. coli O103, E. coli O111, E. coli O121 and E. coli O145 to perform a simple agglutination test. This kit is a great addition to our line of products for the detection of STEC especially when used in conjunction with our ProlisaTM EHEC EIA Kit (PL.2001) and the ProlexTM E.coli O157 Latex Agglutination Kit (PL.070B and PL.071B). Each non-O157 kit comes with a negative control and sufficient agglutination cards and mixing sticks.

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?
50913	Escherichia coli antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GNA	Antisera, All Types, Escherichia Coli

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 58093b9e-727a-4766-814b-09cd2d1e2284
Public Version Date: January 03, 2023
Public Version Number: 1
DI Record Publish Date: December 26, 2022