AccessGUDID - DEVICE: MGB Alert® Parvovirus Primer Mix ASR

GUDID

Device Identifier (DI) Information

Brand Name: MGB Alert® Parvovirus Primer Mix ASR - 48 Reactions
Version or Model: M800682
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M800682
Company Name: Elitechgroup Mdx LLC

Primary DI Number: 03661540951176
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117458512 *Terms of Use

Device Description: MGB Alert® Parvovirus B19 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Parvovirus B19. The mix consists of a total of 4.50 nmol of primers per vial in a 1X TE buffer solution. The primers amplify an 88 bp nucleic acid sequence from the VP1 Capsid Protein (VP1u) gene region of Parvovirus B19.

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?
50152	Parvovirus B19 nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Parvovirus B19 in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, Specific, Analyte

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
Storage Environment Temperature: less than -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b244b4b7-f630-4fb4-ac39-93897d8599c1
Public Version Date: October 15, 2020
Public Version Number: 2
DI Record Publish Date: September 09, 2020