FDA.reportPublic FDA data

BD BACTEC™ MGIT™ 960 PZA Kit

Primary DI
00382902451280
Brand
BD BACTEC™ MGIT™ 960 PZA Kit
Company
BECTON, DICKINSON AND COMPANY
Model
245128
Catalog number
245128
Device description
BD BACTEC™ MGIT™ 960 PZA Kit
Published
2016-05-19
Public version status
Update
Distribution status
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
MJASUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJASusceptibility Test Powders, AntimycobacterialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021582000BACTEC MGIT 960 PZA KITBecton, Dickinson & CO2002-07-13MJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902451280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902451280003829024512803829024512800382902451280

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kitA collection of reagents or test strips, and other associated materials, containing multiple antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) at specified concentration gradients, intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterials against a specific bacterial microorganism, isolated from a clinical specimen by culture.

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
1
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838091834NAREMEL, INC.MJA2016-12-09
30382902451151BD BACTEC™ MGIT™ 960 PZA MediumBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451235BD BACTEC™ MGIT™ 960 SIRE KitBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451259BD BACTEC™ MGIT™ 960 STR 4.0 KitBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451266BD BACTEC™ MGIT™ 960 INH 0.4 KitBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451570BD BACTEC™ MGIT™ 960 IR KitBECTON, DICKINSON AND COMPANYMJA2016-05-19