FDA.reportPublic FDA data

N/A

Primary DI
00382903492015
Brand
N/A
Company
Becton, Dickinson And Company
Model
349201
Catalog number
349201
Device description
BD® CD3 (SK7) FITC
Published
2016-06-08
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
LIZAssay, t lymphocyte surface marker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIZAssay, T Lymphocyte Surface MarkerHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K842218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K842218000ANTI-LEU-4 FITC LYSIN C BUFFERBd Becton Dickinson Vacutainer Systems Preanalytic1984-12-27LIZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382903492015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382903492015003829034920153829034920150382903492015

GMDN Terms#

Term, Definition table
TermDefinition
Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple cell markers expressed on normal and/or aberrant mature lymphocytes [B lymphocytes, T lymphocytes and natural killer (NK) cells] in a clinical specimen, using a fluorescent activated cell sorting/flow cytometry (FACS/Flow) 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
Lot or batch
true
Expiration date on label
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
00382903405428N/ABecton, Dickinson And CompanyLIZ2016-06-27