FDA.reportPublic FDA data

Colibrí™ Primary Tube with Saline

Primary DI
18052870817966
Brand
Colibrí™ Primary Tube with Saline
Company
COPAN WASP SRL
Model
WR090-01-0011
Catalog number
WR090-01-0011
Device description
Colibrí™ Primary Tube with Saline
Published
2024-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2
QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesMicrobiology2
QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass SpectrometryMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18052870817966PrimaryGS10
58052870817964Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805287081796618052870817966
5805287081796458052870817964

GMDN Terms#

Term, Definition table
TermDefinition
Buffered isotonic saline reagent IVDA buffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.

Contacts#

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

Regulatory Flags#

DUNS number
434263590
Device count
50
Lot or batch
true
Expiration 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
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
18050148212864Colibri SpreaderWR090-01-0605TWR090-01-0605T2022-11-15

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