AccessGUDID - DEVICE: ihcDirect® Cytokeratin 7 Ab (00850000596146)

GUDID

Device Identifier (DI) Information

Brand Name: ihcDirect® Cytokeratin 7 Ab
Version or Model: K32015-005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: K32015-005
Company Name: NOVODIAX, INC.

Primary DI Number: 00850000596146
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 965326957 *Terms of Use

Device Description: Clone R284

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?
57073	Cytokeratin IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple cytokeratin subtype(s) in a clinical specimen, using an enzyme immunohistochemistry method.	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: 68e9ba6d-a620-4a09-926d-382cd011f186
Public Version Date: August 10, 2021
Public Version Number: 2
DI Record Publish Date: June 22, 2020