FITC TdT Negative Control IgG1 8100

GUDID B7828100A02

Analyte Specific Reagent FITC conjugated mouse IgG1 negative control 0.5 mL vial for approximately 50 tests

SUPERTECHS, INC

Terminal deoxynucleotidyl transferase (TdT) IVD, control

• Primary Device ID: B7828100A02
• NIH Device Record Key: dfc5d4a7-6cac-4d68-a388-aaf4acfac51e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FITC TdT Negative Control IgG1
• Version Model Number: 8100A
• Catalog Number: 8100
• 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 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to light
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B7828100A02 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-08
• Device Publish Date: 2023-07-31

Devices Manufactured by SUPERTECHS, INC

• B7828100A02 - FITC TdT Negative Control IgG1: 2023-08-08Analyte Specific Reagent FITC conjugated mouse IgG1 negative control 0.5 mL vial for approximately 50 tests
• B7828100A02 - FITC TdT Negative Control IgG1: 2023-08-08 Analyte Specific Reagent FITC conjugated mouse IgG1 negative control 0.5 mL vial for approximately 50 tests
• 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: 2019-11-27 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