AccessGUDID - DEVICE: Spot Indole Reagent (10ml) (05060472466785)

GUDID

Device Identifier (DI) Information

Brand Name: Spot Indole Reagent (10ml)
Version or Model: PL.391-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL.391-10
Company Name: PRO-LAB, INCORPORATED

Primary DI Number: 05060472466785
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 960418395 *Terms of Use

Device Description: The active ingredient in our Spot Indole Reagent is p-dimethylaminocinnamaldehyde (PACA). The reagent will turn blue in the presence of Indole produced during Tryptophan degradation.

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?
43714	Tryptophan utilization/spot indole microbial reagent IVD	A reactant intended to be used in microbial testing to detect tryptophan metabolites (e.g., indole, indole-pyruvic acid) produced via enzymatic breakdown by a microorganism isolated from a clinical specimen by culture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSF	Culture Media, Single Biochemical Test

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: de2669cc-ad64-4a63-b76a-885ae4e0f73b
Public Version Date: December 28, 2022
Public Version Number: 1
DI Record Publish Date: December 20, 2022