AccessGUDID - DEVICE: LT Brucella Antisera Test Reagents (06974621793235)

GUDID

Device Identifier (DI) Information

Brand Name: LT Brucella Antisera Test Reagents
Version or Model: BAT-A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Zhuhai Longtime Biological Technology Co., Ltd

Primary DI Number: 06974621793235
Issuing Agency: GS1
Commercial Distribution End Date: August 05, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 708328288 *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:	Yes
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?
62366	Multiple Brucella species total antibody IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to multiple species of Brucella bacteria in a clinical specimen, using an agglutination method. It is commonly used for the detection of infection with or exposure to Bordetella bacteria which may include B. abortus and B. melitensis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GSM	Antisera, Fluorescent, Brucella Spp.

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: bf2df005-0a43-4d8f-bc81-e5383cc11996
Public Version Date: August 16, 2024
Public Version Number: 2
DI Record Publish Date: August 01, 2023