FDA.reportPublic FDA data

WASP-FLO™

Primary DI
58052870811115
Brand
WASP-FLO™
Company
COPAN WASP SRL
Model
W091
Catalog number
W091
Device description
WASP-FLO™
Published
2021-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQPCalculator/Data Processing Module, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58052870811115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5805287081111558052870811115

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory container robotic transfer system IVD, automatedAn assembly of electrically-powered robotic devices, or stand-alone device, intended to be used for the automated transfer of assay containers (e.g., test tubes, microplates) between processing stations, as part of a pre-set algorithm or assay procedure. The system may interface with one or multiple individual instruments and/analysers, transferring assay containers between stations which may include specimen pipetting, reagent dispensing, incubation, microplate washing, agitation, barcode reading and/or optical reading. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390302687218wasp@copangroup.com

Regulatory Flags#

DUNS number
434263590
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
58059796363919Slide Prep Evo™W086-40NW086-40N2026-02-26
58059796363926Pipettor ModuleW086-090W086-0902026-02-26
58050148211438WASPLab® Single IncubatorW087-011W087-0112021-04-27
58050148211445WASPLab® Double IncubatorW087-012W087-0122021-04-27
58050148211476WASPLab® ConveyorW087-010W087-0102021-04-27
58050148212060WASPLab®W087W0872021-04-27
58050148218277Pipettor ModuleW086-090W086-0902021-04-27
58050148218970Slide Prep Evo™W086-40NW086-40N2021-04-27
58059796360857PhenoMATRIXWLAB-PHENOMATRIXWLAB-PHENOMATRIX2026-02-13
18050148217975Colibrí™ Primary Tube with WaterWR090-01-0003WR090-01-00032024-01-31
18052870817966Colibrí™ Primary Tube with SalineWR090-01-0011WR090-01-00112024-01-31
58059796363506WASP®W086W0862024-11-21
58050148211414WASP®W086W0862021-04-27
58059796363933WASPLab®W087W0872024-06-04
58059796363940WASPLab® ConveyorW087-010W087-0102024-06-04
58059796363957WASPLab® Single IncubatorW087-011W087-0112024-06-04
58059796363964WASPLab® Double IncubatorW087-012W087-0122024-06-04
58050148217973Colibrí™ Primary Tube with WaterWR090-01-0003WR090-01-00032024-01-31
58052870817964Colibrí™ Primary Tube with SalineWR090-01-0011WR090-01-00112024-01-31
08050148218005Colibri Daily Verification KitWR090-01-0004WR090-01-00042022-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142373012SoftPathSCC SOFT COMPUTERJQP2026-05-29
00810142374064SoftBiobankSCC SOFT COMPUTERJQP2026-05-05
00810142373975SoftBiochemistrySCC SOFT COMPUTERJQP2026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTERJQP2026-04-16
00810142373999SoftPathDxSCC SOFT COMPUTERJQP2026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTERJQP2026-04-16
00810142374019SoftHLASCC SOFT COMPUTERJQP2026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTERJQP2026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTERJQP2026-04-16
00810142374040SoftTrackSCC SOFT COMPUTERJQP2026-04-16
00810142373586SoftTotalQCSCC SOFT COMPUTERJQP2026-03-28
00810142373715SoftBiochemistrySCC SOFT COMPUTERJQP2026-03-12
00810142373722SoftCytogeneticsSCC SOFT COMPUTERJQP2026-03-12
00810142373739SoftPathDxSCC SOFT COMPUTERJQP2026-03-12
00810142373746SoftFlowCytometrySCC SOFT COMPUTERJQP2026-03-12
00810142373753SoftHLASCC SOFT COMPUTERJQP2026-03-12
00810142373760SoftMolecularSCC SOFT COMPUTERJQP2026-03-12
00810142373777SoftGenomicsSCC SOFT COMPUTERJQP2026-03-12
00810142373784SoftTrackSCC SOFT COMPUTERJQP2026-03-12
00810142373340SoftTotalQCSCC SOFT COMPUTERJQP2026-03-11
00810142373593SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-21
00810142373609SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-21
00810142373616SoftPathDxSCC SOFT COMPUTERJQP2026-02-21
00810142373623SoftFlowCytometrySCC SOFT COMPUTERJQP2026-02-21
00810142373630SoftHLASCC SOFT COMPUTERJQP2026-02-21
00810142373647SoftMolecularSCC SOFT COMPUTERJQP2026-02-21
00810142373654SoftGenomicsSCC SOFT COMPUTERJQP2026-02-21
00810142373661SoftTrackSCC SOFT COMPUTERJQP2026-02-21
00810142373500SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-04
00810142373517SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-04