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
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
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