AccessGUDID - DEVICE: Northeast Laboratory Services (00810144911250)

GUDID

Device Identifier (DI) Information

Brand Name: Northeast Laboratory Services
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X1500
Company Name: Northeast Laboratory Services, Inc.

Primary DI Number: 00810144911250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071749709 *Terms of Use

Device Description: Methyl Red Indicator

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:	No
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?
43509	Voges-Proskauer (VP) microbial reagent IVD	One or multiple substances or reactants, referred to as VP (Voges-Proskauer) reagent, intended to be used in microbial testing to determine the ability of a microorganism, isolated from a clinical specimen by culture, to convert pyruvate to acetoin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	Discs, Strips And Reagents, Microorganism Differentiation

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: Yes
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: 7245f594-5255-4e9e-9e0d-b74a3d6af28a
Public Version Date: September 29, 2023
Public Version Number: 1
DI Record Publish Date: September 21, 2023