FDA.reportPublic FDA data

Platelia

Primary DI
03610522189380
Brand
Platelia
Company
BIO-RAD
Model
12014064
Catalog number
12014064
Device description
Platelia Aspergillus Ag
Published
2023-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOMANTIGEN, GALACTOMANNAN, ASPERGILLUS SPP.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOMAntigen, Galactomannan, Aspergillus Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093678000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093678000PLATELIA ASPERGILLUS EIA MODEL 62793Bio-Rad2011-01-13NOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610522189380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610522189380036105221893803610522189380

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of galactomannan antigens from multiple species of the fungus Aspergillus, which may include Aspergillus niger, Aspergillus flavus, Aspergillus terreus and/or Aspergillus fumigatus, in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723techsupport.ussd-redmond@bio-rad.com

Regulatory Flags#

DUNS number
269902602
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610522220526Platelia12015253120152532023-07-03
03610520002933Select63747637472016-08-16
03610520007860PLATELIA25296252962016-08-16
03610520007877PLATELIA25297252972016-08-16
03610522220519Platelia12015289120152892023-07-03
03610520010785GEENIUS92465924652023-02-03
03610520013328EVOLIS89601896012023-02-03
03610520013571PR 410091587915872023-02-03
03610520014103BIO-RAD87530875302023-02-03
03610520002940Select63748637482023-01-05
03610520034309Select63740637402023-01-05
03610520000953Pastorex56353563532022-12-22
03610520000960Pastorex56356563562022-12-22
03610520002490Platelia62786627862022-12-22
03610520002902Select63726637262022-12-22
03610520002919Select63727637272022-12-22
03610520002971Select63751637512016-08-16
03610520007853PLATELIA26211262112016-08-16
03610520013847Geenius 72461724612015-01-12
03610520013854Geenius723392015-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009979543MycoMEIA Aspergillus Assay Pearl DiagnosticsNOM2026-03-16
00860009979550MycoMEIA Aspergillus Assay Sample Processing ColumnsPearl DiagnosticsNOM2026-03-16
00860009979567MycoMEIA Aspergillus Assay 25X Concentrated Wash Solution Pearl DiagnosticsNOM2026-03-16
00860009979574MycoMEIA Aspergillus Assay Uncoated Plates Pearl DiagnosticsNOM2026-03-16