FDA.reportPublic FDA data

N/A

Primary DI
00382903401833
Brand
N/A
Company
Becton, Dickinson And Company
Model
340183
Catalog number
340183
Device description
HLA-B27 Kit Tests IVD
Published
2020-12-01
Public version status
Update
Distribution status
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
00382903401833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382903401833003829034018333829034018330382903401833

GMDN Terms#

Term, Definition table
TermDefinition
White blood cell count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen using a manual, semi-automated or automated cell count method.

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(877)232-8995BDBCustomerService@bd.com

Regulatory Flags#

DUNS number
119218200
Device count
1
Kit
true
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
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
00382906579874N/ABECTON, DICKINSON AND COMPANYMZI2021-01-07
00382906407764N/ABECTON, DICKINSON AND COMPANYMZI2020-12-17
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