FDA.reportPublic FDA data

N/A

Primary DI
00382906666451
Brand
N/A
Company
Becton, Dickinson And Company
Model
666645
Catalog number
666645
Device description
BD® Anti-Human IgD (IA6-2) PerCP-Cy5.5
Published
2025-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, specific, analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382906666451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906666451003829066664513829066664510382906666451

GMDN Terms#

Term, Definition table
TermDefinition
Interferon gamma release IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of interferon gamma (IFN gamma) released in response to T-cell activation resulting from stimulation by one or multiple specific antigens or mitogens, including (but not limited to) B Borrelia species, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), BK virus, severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), and/or Mycobacterium species.

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
00382906718167HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718174HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718181HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718198HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718204HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718211HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718235HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718242HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718259HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718266HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718273HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718280HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718310HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718327HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718334HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718341HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718358Not ApplicableBecton, Dickinson And CompanyMVU2026-09-24
00382906718365HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718372HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718389HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718396HorizonBecton, Dickinson And CompanyMVU2026-09-24
00840542202094Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202100Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202117Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202186Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202193Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202209Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202216Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202223Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202230Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22