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 Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control Immunoglobulin-sensitized reagent red blood cell IVD, control

• Primary Device ID: 20858400005095
• NIH Device Record Key: 4606e578-29d6-4c56-8e44-99307c84b0c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control Cells
• Version Model Number: 510400/510402
• Company DUNS: 003255213
• Company Name: AMERICAN NATIONAL RED CROSS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858400005091 [Primary]
GS1	10858400005098 [Package]; Contains: 00858400005091; Package: Box [3 Units]; In Commercial Distribution
GS1	20858400005095 [Package]; Contains: 00858400005091; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK090021

FDA Product Code

• KSF: Kit, Quality Control For Blood Banking Reagents

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-21

Devices Manufactured by AMERICAN NATIONAL RED CROSS

• 00858400005114 - Red Cell Storage Solution: 2020-07-27 Red Cell Storage Solution is intended for use in the dilution and/or preservation of human red blood cells (RBCs) for the purpos
• 10858400005104 - PEG: 2018-10-18 PEG is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. T
• 10858400005128 - LISS: 2018-10-18 LISS is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing.
• 00858400005084 - DailyChek QC Kit: 2018-07-06 Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells.
• 00858400005008 - Anti-K: 2018-03-29 Blood Grouping Reagent
• 00858400005015 - Anti-k: 2018-03-29 Blood Grouping Reagent
• 00858400005022 - Anti-Kpa: 2018-03-29 Blood Grouping Reagent
• 00858400005039 - Anti-Kpb: 2018-03-29 Blood Grouping Reagent