FDA.reportPublic FDA data

Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63)

Primary DI
23661562495584
Brand
Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63)
Company
DIAGAST
Model
B49558
Catalog number
B49558
Device description
Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems
Published
2020-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23661562495584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2366156249558423661562495584

GMDN Terms#

Term, Definition table
TermDefinition
Anti-E [RH005] red blood cell grouping IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for E [RH005] red blood cell antigens from the rhesus system, using an agglutination 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
800-447-5852xxx@xx.xx

Regulatory Flags#

DUNS number
381527001
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
23661562173192Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63)17319173192015-09-04
23661562173178Beckman Coulter® PK® Systems Control17317173172016-01-12
23661562173307Beckman Coulter® PK® Systems Bromelin17330173302015-09-18
23661562105469Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Green2105462105462018-05-01
23661562105476Anti-Human Globulin Anti-IgG - Green2105472105472018-05-01
23661562105490Anti-Human Globulin Anti-IgG - Clear2105492105492018-05-01
23661562105506Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Clear2105502105502018-05-01
23661562105209Anti-A (AB01)2105202105202018-05-01
23661562105216Anti-B (AB02)2105212105212018-05-01
23661562105223Anti-A,B (AB03)2105222105222018-05-01
23661562105247Anti-D (RH1) IgG2105242105242018-05-01
23661562105254Anti-D (RH1) IgM2105252105252018-05-01
23661562105278Anti-C (RH2)2105272105272018-05-01
23661562105285Anti-c (RH4)2105282105282018-05-01
23661562105292Anti-E (RH3)2105292105292018-05-01
23661562105308Anti-e (RH5)2105302102302018-05-01
23661562105315Anti-Fya (FY1)2105312105312018-05-01
23661562105322Anti-Fyb (FY2)2105322105322018-05-01
23661562105339Anti-K (KEL1)2105332105332018-05-01
23661562105346Anti-Jka (JK1)2105342105342018-05-01