AccessGUDID - DEVICE: ihcDirect® TROP2 Ab Conjugate 5mL (00850030934819)

GUDID

Device Identifier (DI) Information

Brand Name: ihcDirect® TROP2 Ab Conjugate 5mL
Version or Model: H32044-R005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K32044-005
Company Name: NOVODIAX, INC.

Primary DI Number: 00850030934819
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965326957 *Terms of Use
Previous DI: 00850000596825

Device Description: R1011

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?
65123	Trophoblast antigen 2 (TROP2) IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of the protein trophoblast antigen 2 (TROP2) in a clinical specimen.	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
Handling Environment Temperature: between 21 and 30 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: 730b18bf-e8f2-48ea-899c-2501d9c95ec4
Public Version Date: August 30, 2021
Public Version Number: 1
DI Record Publish Date: August 20, 2021