FDA.reportPublic FDA data

N/A

Primary DI
00382906579874
Brand
N/A
Company
BECTON, DICKINSON AND COMPANY
Model
657987
Catalog number
657987
Device description
BD® HLA-B27 Application Module v2.0
Published
2021-01-07
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
MZITest, qualitative, for HLA, non-diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZITest, Qualitative, For Hla, Non-DiagnosticUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK050073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK050073000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382906579874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906579874003829065798743829065798740382906579874

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)232-8995BDBCustomerService@bd.com

Regulatory Flags#

DUNS number
024230633
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24
00382906718365Horizon6718366718362026-09-24
00382906718372Horizon6718376718372026-09-24
00382906718389Horizon6718386718382026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888234500858MatchXIMMUCOR GTI DIAGNOSTICS, INC.MZI2025-09-30
10888234500841LIFECODES LifeScreen XPIMMUCOR GTI DIAGNOSTICS, INC.MZI2023-07-11
10888234400332LIFECODES LSA Class I IMMUCOR GTI DIAGNOSTICS, INC.MZI2022-04-06
10888234400349LIFECODES LSA Class II IMMUCOR GTI DIAGNOSTICS, INC.MZI2022-04-06
10888234500810LIFECODES MATCH IT! Antibody SoftwareIMMUCOR GTI DIAGNOSTICS, INC.MZI2022-02-18
00382906434388N/ABECTON, DICKINSON AND COMPANYMZI2021-01-19
00382906407764N/ABECTON, DICKINSON AND COMPANYMZI2020-12-17
00382903401833N/ABecton, Dickinson And CompanyMZI2020-12-01
00812117015484PE-Conjugated StreptavidinONE LAMBDA, INC.MZI2020-06-04
00812117010199LABScreen™ Single Antigen HLA Class I ExPlexONE LAMBDA, INC.MZI2020-06-03
00812117014654LABScreen™ Single Antigen HLA Class II ExPlexONE LAMBDA, INC.MZI2020-06-03
10888234500827Dilution SolutionIMMUCOR GTI DIAGNOSTICS, INC.MZI2020-05-20
10888234500803LIFECODES MATCH IT!™ DNA Software v1.3IMMUCOR GTI DIAGNOSTICS, INC.MZI2020-02-26
07611969965700Lymphoscreen ABC-60Bio-Rad Medical Diagnostics GmbHMZI2018-03-08
07611969965717Lymphoscreen DR 30x2Bio-Rad Medical Diagnostics GmbHMZI2018-03-08
10888234400011LIFECODES HLA-A eRES SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400028LIFECODES HLA-B SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400035LIFECODES HLA-B eRES SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400059LIFECODES HLA-C eRES SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400066LIFECODES HLA-DRB1 SSO Typing Kit for use with LumineIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400073LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400080LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400134LIFECODES TAQ PolymeraseIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400295LIFECODES Class I ID Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400301LIFECODES Class II IDv2 for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400318LIFECODES LifeScreen DeluxeIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400394LIFECODES MATCH IT!™ DNA Software v1.2IMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400462LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400479LIFECODES HLA-DPA1/B1 SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400509Conjugate ConcentrateIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15