FDA.reportPublic FDA data

BD BBL™ Crystal™ ANR, GP, RGP, N/H ID Inoculum Fluid

Primary DI
30382902450383
Brand
BD BBL™ Crystal™ ANR, GP, RGP, N/H ID Inoculum Fluid
Company
BECTON, DICKINSON AND COMPANY
Model
245038
Catalog number
245038
Device description
BD BBL™ Crystal™ ANR, GP, RGP, N/H ID Inoculum Fluid
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSPKIT, ANAEROBIC IDENTIFICATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSPKit, Anaerobic IdentificationMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902450383PrimaryGS10
00382902450382Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290245038330382902450383
00382902450382003829024503823829024503820382902450382

GMDN Terms#

Term, Definition table
TermDefinition
Inoculation fluid IVDA solution intended to be used to re-suspend and dilute an isolated pure microbial culture from a clinical specimen, in preparation for subsequent testing. The solution is intended to rehydrate dried biochemical and enzymatic substrates to initiate test reactions.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 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
10
Lot or batch
true
Expiration 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
15099590657352MicroScanBeckman Coulter, Inc.JSP2022-12-05
05032384028528PET RPLA KITOXOID LIMITEDJSP2022-12-04
15099590655907MicroScanBeckman Coulter, Inc.JSP2022-11-15
15099590655983MicroScanBeckman Coulter, Inc.JSP2022-11-15
00848838058035Remel REMEL, INC.JSP2021-11-12
30848838058036Remel REMEL, INC.JSP2021-11-12
03848838058032Remel REMEL, INC.JSP2021-11-12
03573026529727VITEK® 2 ANCBIOMERIEUX , INC.JSP2020-06-02
03573026144364VITEK® 2 ANCBIOMERIEUX , INC.JSP2020-06-02
03573026588564RAPID ID 32 ABIOMERIEUX SAJSP2020-04-10
03573026048150API® 20 ABIOMERIEUX SAJSP2020-04-10
03573026066420rapid ID 32 ABIOMERIEUX SAJSP2020-04-10
30382902450109BD BBL™ Crystal™ ANRBECTON, DICKINSON AND COMPANYJSP2018-05-25
00382902450115BD BBL™ Crystal™ ID Systems Anaerobe Manual CodebookBECTON, DICKINSON AND COMPANYJSP2018-05-25