FDA.reportPublic FDA data

BD Kiestra™ IdentifA

Primary DI
00382904440633
Brand
BD Kiestra™ IdentifA
Company
BECTON, DICKINSON AND COMPANY
Model
444063
Catalog number
444063
Device description
BD Kiestra™ IdentifA
Published
2023-05-31
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
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
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
K191964000
K222563000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191964000BD Kiestra IdentifABecton, Dickinson and Company2021-11-03QQV
K222563000BD Kiestra IdentifABecton, Dickinson and Company2023-08-31QQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904440633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904440633003829044406333829044406330382904440633

GMDN Terms#

Term, Definition table
TermDefinition
Microbial specimen inoculation/streaking/colony-picking instrument IVDAn electrically-powered instrument intended for the pre-analytical preparation of microbial samples (e.g., cultures, suspensions, MALDI-TOF targets/slides) from a clinical specimen and/or culture isolate. Its functionality includes: 1) automated/semi-automated transfer of the clinical specimen (e.g., by aspiration or inoculating loop), inoculation into/onto culture dishes/tubes/slides, and streaking of culture dishes (e.g., using magnetic beads, inoculation loops or spreaders); and/or 2) automated microbial colony picking for the preparation of samples for subsequent analytical procedures. It may also feature processing capabilities such as barcoding, storage, and/or sorting.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth860Millimeter
Height1700Millimeter
Weight550Kilogram
Width1060Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24
00382906718365Horizon6718366718362026-09-24
00382906718372Horizon6718376718372026-09-24
00382906718389Horizon6718386718382026-09-24

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Primary DI, Brand, Company table
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03573026637200VITEK® MS SOFTWARE v1.2BIOMERIEUX SAQBN2025-04-29
03573026626211VITEK®MSBIOMERIEUX SAQBN2024-03-08
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18050148217975Colibrí™ Primary Tube with WaterCOPAN WASP SRLQQV2024-01-31
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18052870817966Colibrí™ Primary Tube with SalineCOPAN WASP SRLQBN2024-01-31
58050148217973Colibrí™ Primary Tube with WaterCOPAN WASP SRLQBN2024-01-31
58052870817964Colibrí™ Primary Tube with SalineCOPAN WASP SRLQBN2024-01-31
03573026628154VITEK® MS knowledge base v3.3BIOMERIEUX SAQBN2023-11-14
08050148218005Colibri Daily Verification KitCOPAN WASP SRLQBN2022-11-15
08050148218005Colibri Daily Verification KitCOPAN WASP SRLQQV2022-11-15
18050148212864Colibri SpreaderCOPAN WASP SRLQBN2022-11-15
18050148212864Colibri SpreaderCOPAN WASP SRLQQV2022-11-15
18050148217968Colibrí™ Primary Tube for VITEK 2COPAN WASP SRLQBN2022-11-15
18050148217968Colibrí™ Primary Tube for VITEK 2COPAN WASP SRLQQV2022-11-15
58050148218208Colibrí™COPAN WASP SRLQQV2022-11-15
58050148218208Colibrí™COPAN WASP SRLQBN2022-11-15
03573026611422VITEK® MS PRIMEBIOMERIEUX SAQBN2022-04-25
58052870816202Colibrí™ SystemCOPAN WASP SRLQQV2022-01-27
58052870816202Colibrí™ SystemCOPAN WASP SRLQBN2022-01-27
58052870818428Colibrí™ Vision SystemCOPAN WASP SRLQQV2022-01-27
58052870818428Colibrí™ Vision SystemCOPAN WASP SRLQBN2022-01-27
58052870818435Colibrí™ Preparation StationCOPAN WASP SRLQQV2022-01-27
58052870818435Colibrí™ Preparation StationCOPAN WASP SRLQBN2022-01-27
03573026621698VITEK® MS SOFTWARE v1.1BIOMERIEUX SAQBN2021-11-03