AccessGUDID - DEVICE: Mast Assure Escherichia coli O111 Antiserum (15060392376260)

GUDID

Device Identifier (DI) Information

Brand Name: Mast Assure Escherichia coli O111 Antiserum
Version or Model: M12016
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M12016
Company Name: MAST GROUP LIMITED

Primary DI Number: 15060392376260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 212623821 *Terms of Use

Device Description: M12016 - Escherichia coli Monovalent O Antiserum - Factor O111 - 2ml

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):	Yes
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?
62451	Escherichia coli multiple strain culture isolate antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative detection of antigens from multiple strains of Escherichia coli (E. coli) bacteria [e.g., O86: K61, O114: K90, O125: K70, O127: K63, O128: K67, O44: K74, O112: K66, O124: K72, O142: K86] isolated by culture from a clinical specimen, using an agglutination method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GNA	Antisera, All Types, Escherichia Coli

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: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 459433fb-2ac0-497c-8b34-83df85152693
Public Version Date: September 17, 2018
Public Version Number: 1
DI Record Publish Date: August 17, 2018