FDA.reportPublic FDA data

BD BBL™ Crystal™ ANR

Primary DI
30382902450109
Brand
BD BBL™ Crystal™ ANR
Company
BECTON, DICKINSON AND COMPANY
Model
245010
Catalog number
245010
Device description
BD BBL™ Crystal™ ANR
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
30382902450109PrimaryGS10
00382902450108Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290245010930382902450109
00382902450108003829024501083829024501080382902450108

GMDN Terms#

Term, Definition table
TermDefinition
Multiple anaerobic bacteria species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of anaerobic bacteria isolated by culture from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382902780519BD Macro-Vue™ Card Test Rotator2780512780512016-05-19
00885403522324Swan-Ganz151F7151F72026-07-31
00885403523581VAMP48VMP10648VMP1062026-07-31
00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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
30382902450383BD BBL™ Crystal™ ANR, GP, RGP, N/H ID Inoculum FluidBECTON, DICKINSON AND COMPANYJSP2018-05-25
00382902450115BD BBL™ Crystal™ ID Systems Anaerobe Manual CodebookBECTON, DICKINSON AND COMPANYJSP2018-05-25