FDA.reportPublic FDA data

Colibri Daily Verification Kit

Primary DI
08050148218005
Brand
Colibri Daily Verification Kit
Company
COPAN WASP SRL
Model
WR090-01-0004
Catalog number
WR090-01-0004
Device description
Colibri Daily Verification Kit
Published
2022-11-15
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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220546000Colibrí SystemCopan Wasp Srl2022-10-05LON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08050148218005PrimaryGS10
58050148218000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050148218005080501482180058050148218005
5805014821800058050148218000

GMDN Terms#

Term, Definition table
TermDefinition
Optical instrument performance standard calibrator/control IVD, single-useA reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical instrument (e.g., spectrophotometer, nephelometer, microplate reader, PCR instrument, flow cytometer). Verification/optimization functions may include optical density (absorbance/scattering), fluorescent/luminescent accuracy and compensation, linearity at specified wavelengths and/or stray light interference. It may be used to verify pipetting/dispensing/aspiration/diluting functions of an instrument using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
434263590
Device count
2
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
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
18050148212864Colibri SpreaderWR090-01-0605TWR090-01-0605T2022-11-15

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