BioCode MDx 3000 Optical Calibration and Verification Kit

Primary DI
00851034007028
Brand
BioCode MDx 3000 Optical Calibration and Verification Kit
Company
APPLIED BIOCODE, INC.
Model
1
Catalog number
64-C0002
Device description
Kit containing calibrators and controls for MDx 3000.
Published
2019-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851034007028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851034007028008510340070288510340070280851034007028

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gastrointestinal pathogen nucleic acid IVD, calibratorA material which is used to establish known points of reference for as assay intended to be used for the quantitative and/or qualitative detection of nucleic acid from multiple microorganisms associated with gastrointestinal disease, in a clinical specimen. Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004580003
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851034007004BioCode MDx 3000141-A00512018-10-15
00851034007073BioCode Respiratory Pathogen Panel0163-R00012020-01-10
00851034007011Gastrointestinal Pathogen Panel (GPP) Kit12018-10-15
00851034007035BioCode MDx 3000 Buffer A12019-07-30
00851034007042BioCode SA-PE Mix Pack12019-07-30
00851034007059BioCode 2500 Multiplex Detection System141-A00052018-08-22