AccessGUDID - DEVICE: Histostain® Plus Rabbit Primary (10190302008235)

GUDID

Device Identifier (DI) Information

Brand Name: Histostain® Plus Rabbit Primary
Version or Model: 856743
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LIFE TECHNOLOGIES CORPORATION

Primary DI Number: 10190302008235
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 080131636 *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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
56920	Multiple CD cell marker 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 qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.	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: 45c17077-79ec-402f-b7ab-cd5126d1026c
Public Version Date: December 02, 2019
Public Version Number: 5
DI Record Publish Date: February 02, 2018