TdT Control Cell Suspension 9500

GUDID B7829500A07

Cell suspension containing fixed human lymphoblastoid REH (TdT+) and RA-1 (TdT-) cells 50% TdT+ and 50% TdT- cells at a concentration of 2 x 10^7 cells/mL 1.0 mL bottle for approximately 20 tests

SUPERTECHS, INC

Terminal deoxynucleotidyl transferase (TdT) IVD, control

• Primary Device ID: B7829500A07
• NIH Device Record Key: 4e9f780d-d458-454c-a8bc-7735be7dd124
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TdT Control Cell Suspension
• Version Model Number: 9500A
• Catalog Number: 9500
• Company DUNS: 071245690
• Company Name: SUPERTECHS, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 4 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B7829500A07 [Primary]

FDA Product Code

• KIR: Cells, Animal And Human, Cultured

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-10-08

Devices Manufactured by SUPERTECHS, INC

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• B7828200A03 - FITC TdT Negative Control IgG2a: 2023-08-08 Analyte Specific Reagent FITC conjugated mouse IgG2a negative control 0.5 mL vial for approximately 50 tests
• B7829500A07 - TdT Control Cell Suspension: 2019-11-27Cell suspension containing fixed human lymphoblastoid REH (TdT+) and RA-1 (TdT-) cells 50% TdT+ and 50% TdT- cells at a concentration of 2 x 10^7 cells/mL 1.0 mL bottle for approximately 20 tests
• B7829500A07 - TdT Control Cell Suspension: 2019-11-27 Cell suspension containing fixed human lymphoblastoid REH (TdT+) and RA-1 (TdT-) cells 50% TdT+ and 50% TdT- cells at a concentr
• B7826600C07 - FITC TdT Reagent: 2019-09-25 Analyte Specific Reagent FITC conjugated mouse anti-human TdT clone 6 (IgG1)
• B7826600A05 - FITC TdT Reagent: 2019-09-24 Analyte Specific Reagent FITC conjugated mouse anti-human TdT clone 6 (IgG1) 0.5 mL vial for approximately 50 tests
• B7826600D08 - FITC TdT Reagent: 2019-09-24 Analyte Specific Reagent FITC conjugated mouse anti-human TdT clone 6 (IgG1) 10.0 mL bottle for approximately 1000 tests