AccessGUDID - DEVICE: Rabbit Monoclonal Anti-Human Serum Amyloid A Antibody, EP335 (00810113068213)

GUDID

Device Identifier (DI) Information

Brand Name: Rabbit Monoclonal Anti-Human Serum Amyloid A Antibody, EP335
Version or Model: AC-0311A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Epitomics Inc.

Primary DI Number: 00810113068213
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118926596 *Terms of Use

Device Description: Rabbit Monoclonal Anti-Human Serum Amyloid A (335), 0.1 mL concentrated

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?
53457	Serum amyloid A IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the apolipoprotein, serum amyloid A 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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.1 Milliliter

Device Record Status

Public Device Record Key: 86f056dc-1414-42fe-a509-fae76c76ebcc
Public Version Date: June 29, 2023
Public Version Number: 1
DI Record Publish Date: June 21, 2023