AccessGUDID - DEVICE: NeoPATH Pro Universal Negative Control Serum (00847627039781)

GUDID

Device Identifier (DI) Information

Brand Name: NeoPATH Pro Universal Negative Control Serum
Version or Model: NPRI10028T40
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOCARE MEDICAL LLC

Primary DI Number: 00847627039781
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806617825 *Terms of Use

Device Description: No description.

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):	Yes
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?
66601	Multiple solid tumour differentiation marker IVD, antibody	Multiple immunoglobulins (antibody cocktail) capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple proteins/markers associated with more than one specific tissue or solid tumour (e.g., lung, breast, ovarian, kidney, gastrointestinal, colon) in a clinical specimen. It is typically used in cancer-screening assays to help diagnostic differentiation between solid tumour types through detection of various types of proteins/markers (e.g., homeobox protein CDX-2, cytokeratin 7, GATA3, uroplakin).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	Immunohistochemistry Reagents And Kits

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: 29b79fff-06dd-4252-9590-fa143a912007
Public Version Date: March 28, 2025
Public Version Number: 1
DI Record Publish Date: March 20, 2025