AccessGUDID - DEVICE: PE-Conjugated Streptavidin (00812117015484)

GUDID

Device Identifier (DI) Information

Brand Name: PE-Conjugated Streptavidin
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LSPSAB2
Company Name: ONE LAMBDA, INC.

Primary DI Number: 00812117015484
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118289289 *Terms of Use

Device Description: For use in the detection of biotinylated proteins and nucleic acids in biotinylated proteins and nucleic acids in LABType™ SSO TYPING TESTS and LABType XR and CWD DNA Typing Test assays.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
56398	HLA class I & II antigen tissue typing IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen, using a multiplex method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZI	Test,Qualitative,For Hla,Non-Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: c255879a-5886-4e96-80db-145d24b069a6
Public Version Date: June 12, 2020
Public Version Number: 1
DI Record Publish Date: June 04, 2020