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
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03573026637200VITEK® MS SOFTWARE v1.2BIOMERIEUX SAQBN2025-04-29
03573026626211VITEK®MSBIOMERIEUX SAQBN2024-03-08
03573026617851VITEK®MSBIOMERIEUX SAQBN2024-03-08
18050148217975Colibrí™ Primary Tube with WaterCOPAN WASP SRLQQV2024-01-31
18050148217975Colibrí™ Primary Tube with WaterCOPAN WASP SRLQBN2024-01-31
18052870817966Colibrí™ Primary Tube with SalineCOPAN WASP SRLQQV2024-01-31
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