FDA.reportPublic FDA data

Anti-k

Primary DI
00858400005015
Brand
Anti-k
Company
American National Red Cross
Model
510202
Device description
Blood Grouping Reagent
Published
2014-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858400005015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858400005015008584000050158584000050150858400005015

GMDN Terms#

Term, Definition table
TermDefinition
Anti-k (KEL002) 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 k [KEL002] red blood cell antigens from the Kell system, using an agglutination method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
003255213
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858400005138Anti-C (Human/Murine Monoclonal)5101462026-03-06
00858400005145Anti-c (Human/Murine Monoclonal)5101472026-03-06
00858400005152Anti-S (Human/Murine Monoclonal)5101532026-03-06
00858400005169Anti-s (Human/Murine Monoclonal)5101542026-03-06
00858400005176Anti-k (Human/Murine Monoclonal)(IgG)5101492026-03-06
00858400005183Anti-E (Human/Murine Monoclonal)5101482026-03-06
00858400005190Anti-Jka (Human/Murine Monoclonal)5101512026-03-06
00858400005206Anti-Jkb (Human/Murine Monoclonal)5101522026-03-06
00858400005091Control Cells510400/5104022016-07-21
00858400005107PEG5101792018-09-17
00858400005121LISS5101772018-09-17
00858400005114Red Cell Storage Solution5102652020-07-17
00858400005008Anti-K5102002014-09-12
00858400005022Anti-Kpa5102042014-09-12
00858400005039Anti-Kpb5102052014-09-12
00858400005046Anti-M5102062014-09-12
00858400005053Anti-S5102222014-09-12
00858400005060Anti-s5102242014-09-12
00858400005077Anti-Fya5102152014-09-12
00858400005084DailyChek QC Kit5103952016-07-21