FDA.reportPublic FDA data

Colibrí™ Primary Tube for VITEK 2

Primary DI
18050148217968
Brand
Colibrí™ Primary Tube for VITEK 2
Company
COPAN WASP SRL
Model
WR090-01-0002
Catalog number
WR090-01-0002
Device description
Colibrí™ Primary Tube for VITEK 2
Published
2022-11-15
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

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
18050148217968PrimaryGS10
58050148217966Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805014821796818050148217968
5805014821796658050148217966

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.

Sterilization Methods#

Method table
Method

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30382904490851NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
00382904490850NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
15099590799717MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799724MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799755MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799762MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799243MicroScanBeckman Coulter, Inc.LON2025-12-08
04251204328278MBT Compass HT CABruker Daltonik GmbHQBN2025-11-28
04251204328285MBT HT Sepsityper CA ModuleBruker Daltonik GmbHQBN2025-11-28
04251204328728MBT FAST Shuttle US IVDBruker Daltonik GmbHQBN2025-11-28
03573026647780VITEK® 2 AST-N816BIOMERIEUX , INC.LON2025-11-21
00860012092109LifeScale ASTAffinity Biosensors, LLCLON2025-10-14
00860012092116LSGNAffinity Biosensors, LLCLON2025-10-14
00860012092123LifeScale SensorAffinity Biosensors, LLCLON2025-10-14
03573026615499VITEK® COMPACT PROBIOMERIEUX , INC.LON2025-05-15
03573026618285VITEKBIOMERIEUX , INC.LON2025-05-15
03573026637200VITEK® MS SOFTWARE v1.2BIOMERIEUX SAQBN2025-04-29
30382904490820NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
30382904490837NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
00382904449575BDXpert™ SystemBECTON, DICKINSON AND COMPANYLON2025-03-20
00382904490829NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
00382904490836NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20
00195893563760Selux AST SystemSelux Diagnostics, Inc.LON2024-12-20
00850031114005Bulk Analyzer Reagent PackSelux Diagnostics, Inc.LON2024-12-20
10850031114026Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114036AST InoculatorSelux Diagnostics, Inc.LON2024-12-20
00850031114043AST AnalyzerSelux Diagnostics, Inc.LON2024-12-20