AccessGUDID - DEVICE: Keratin 14 Polyclonal Antibody, Purified. (00810034700049)

GUDID

Device Identifier (DI) Information

Brand Name: Keratin 14 Polyclonal Antibody, Purified.
Version or Model: 905301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 905301
Company Name: BIOLEGEND, INC.

Primary DI Number: 00810034700049
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119240658 *Terms of Use

Device Description: URL: https://www.biolegend.com/en-us/products/keratin-14-polyclonal-antibody-purified-10953

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?
57767	Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers 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
Special Storage Condition, Specify: When stored at or below -20°C, product is stable until the date shown on the label. Avoid repeated freeze-thaw cycles to prevent denaturing the antibody.
Special Storage Condition, Specify: If thawed and stored between 2°C and 8°C, product is stable for 24 months from the date of thaw or until the expiry date on the label, whichever comes first.
Storage Environment Temperature: less than -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 100 Microliter

Device Record Status

Public Device Record Key: f72e14ed-60e9-4963-beb9-dcc25fe72e10
Public Version Date: January 10, 2022
Public Version Number: 1
DI Record Publish Date: December 31, 2021