FDA.reportPublic FDA data

BioCode SA-PE Mix Pack

Primary DI
00851034007042
Brand
BioCode SA-PE Mix Pack
Company
APPLIED BIOCODE, INC.
Model
1
Device description
Fluorescence dye for MDx 3000 assays.
Published
2019-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851034007042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851034007042008510340070428510340070420851034007042

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
562-801-0050tpham@apbiocode.com

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
00851034007028BioCode MDx 3000 Optical Calibration and Verification Kit164-C00022019-07-30
00851034007073BioCode Respiratory Pathogen Panel0163-R00012020-01-10
00851034007011Gastrointestinal Pathogen Panel (GPP) Kit12018-10-15
00851034007035BioCode MDx 3000 Buffer A12019-07-30
00851034007059BioCode 2500 Multiplex Detection System141-A00052018-08-22