AccessGUDID - DEVICE: Viral Transport Media (VTM) 3ml (07898996204631)

GUDID

Device Identifier (DI) Information

Brand Name: Viral Transport Media (VTM) 3ml
Version or Model: MEI00175
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MEI00175
Company Name: A. L. B. LUZ

Primary DI Number: 07898996204631
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 905130480 *Terms of Use

Device Description: The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.

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:	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?
62773	General specimen collection kit IVD, clinical	A collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSM	Culture Media, Non-Propagating Transport
LIO	Device, Specimen Collection

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b02ebd9-c511-49f1-b07a-6a72fc136d98
Public Version Date: July 31, 2024
Public Version Number: 1
DI Record Publish Date: July 23, 2024