Control Cells

GUDID 20858400005095

IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT).

AMERICAN NATIONAL RED CROSS

Immunoglobulin G (IgG) sensitized reagent red blood cell IVD, control
Primary Device ID20858400005095
NIH Device Record Key4606e578-29d6-4c56-8e44-99307c84b0c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameControl Cells
Version Model Number510400/510402
Company DUNS003255213
Company NameAMERICAN NATIONAL RED CROSS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858400005091 [Primary]
GS110858400005098 [Package]
Contains: 00858400005091
Package: Box [3 Units]
In Commercial Distribution
GS120858400005095 [Package]
Contains: 00858400005091
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSFKit, Quality Control For Blood Banking Reagents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-21

Devices Manufactured by AMERICAN NATIONAL RED CROSS

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00858400005169 - Anti-s (Human/Murine Monoclonal)2026-03-16 Blood Grouping Reagent
00858400005176 - Anti-k (Human/Murine Monoclonal)(IgG)2026-03-16 Blood Grouping Reagent
00858400005183 - Anti-E (Human/Murine Monoclonal)2026-03-16 Blood Grouping Reagent
00858400005190 - Anti-Jka (Human/Murine Monoclonal)2026-03-16 Blood Grouping Reagent
00858400005206 - Anti-Jkb (Human/Murine Monoclonal)2026-03-16 Blood Grouping Reagent

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