BIOMIC

Primary DI
00863504000217
Brand
BIOMIC
Company
Giles Scientific, Inc.
Model
V3
Catalog number
BV3
Published
2023-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KZKReader, Zone, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZKReader, Zone, AutomatedMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863504000217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863504000217008635040002178635040002170863504000217

GMDN Terms#

Term, Definition table
TermDefinition
Microbial susceptibility testing interpretive software IVDAn application software program intended to be used for the automated diameter recognition and/or interpretation of inhibition zones on microbial culture plates treated with a single or multiple antimicrobial drugs using a disc diffusion or gradient strip method, to determine the susceptibility, intermediate or resistance categorization of the microbial culture. The software measures inhibition zones by analysing images captured by dedicated devices and/or interprets the detected values according to recognized guidelines and customizable rules. Results are used to guide patient treatment options.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144629342
Device count
1
Serial number
true
Manufacturing date on label
true