FDA.reportPublic FDA data

BD BBL™ Crystal™ ID Systems Gram-Positive Manual Codebook

Primary DI
00382902450375
Brand
BD BBL™ Crystal™ ID Systems Gram-Positive Manual Codebook
Company
BECTON, DICKINSON AND COMPANY
Model
245037
Catalog number
245037
Device description
Codebook Crystal Gram-Positive Manual
Published
2018-05-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LQLGRAM POSITIVE IDENTIFICATION PANEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQLGram Positive Identification PanelMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902450375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902450375003829024503753829024503750382902450375

GMDN Terms#

Term, Definition table
TermDefinition
Microorganism identification analyser IVD, manualA mains electricity (AC-powered) laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens by characterizing their morphology, substrate utilization and/or biochemical reactivity, using growth detection technology which may include immunoassay, colorimetry, chromatography and/or carbon dioxide (CO2) production. The device operates with technician involvement in most procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

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

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

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00848838074363Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTOREMEL, INC.LQL2023-06-20
15099590657338MicroScanBeckman Coulter, Inc.LQL2022-12-05
15099590657581MicroScanBeckman Coulter, Inc.LQL2022-12-05
05032384127498MICROBACT LISTERIA 12L (20 ID'S)OXOID LIMITEDLQL2022-12-04
03573026529994VITEK® 2 GPBIOMERIEUX , INC.LQL2020-06-02
03573026131920VITEK® 2 GPBIOMERIEUX , INC.LQL2020-06-02
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30382902452509BD BBL™ Crystal™ Rapid Gram-Positive ID SystemBECTON, DICKINSON AND COMPANYLQL2018-05-25
30382904480081BD Phoenix™ PIDBECTON, DICKINSON AND COMPANYLQL2018-05-25
00382902450412BD BBL™ Crystal™ ID Systems Rapid Gram-Positive Manual CodebookBECTON, DICKINSON AND COMPANYLQL2018-05-25
15099590704025MicroScanBeckman Coulter, Inc.LQL2018-05-11
15099590704032MicroScanBeckman Coulter, Inc.LQL2018-05-11
M578GNID2SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLQL2016-09-24
15099590657376MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657383MicroScan Beckman Coulter, Inc.LQL2016-09-02
15099590657406MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657475MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657499MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657529MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657543MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657567MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657574MicroScanBeckman Coulter, Inc.LQL2016-09-02