PARAROSANILINE SOLUTION

GUDID 04061838202628

SIGMA-ALDRICH, INC.

Differentiation solution IVD

• Primary Device ID: 04061838202628
• NIH Device Record Key: c7fb34b8-a9e1-4446-b4af-9ca6478352b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARAROSANILINE SOLUTION
• Version Model Number: 1804-15ML
• Company DUNS: 832563121
• Company Name: SIGMA-ALDRICH, 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: false
• 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

• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04061838202628 [Primary]

FDA Product Code

• JCH: Esterase

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-06
• Device Publish Date: 2022-04-28

Devices Manufactured by SIGMA-ALDRICH, INC.

• 04061838789686 - TRIZMA® CONCENTRATE: 2022-11-01
• 04061834129783 - COPPER NITRATE: 2022-10-07
• 04061837283789 - GILL MODIFIED EA SOLUTION: 2022-10-07
• 04061838202628 - PARAROSANILINE SOLUTION: 2022-05-06
• 04061838202628 - PARAROSANILINE SOLUTION: 2022-05-06
• 04061838202895 - PEROXIDASE INDICATOR REAGENT: 2021-11-25
• 04061831973013 - LEUKOCYTE PHOSPHATASE: 2021-10-29
• 04061831981322 - PEROXIDASE (MYELOPEROXIDASE): 2021-10-29
• 04061833024386 - AS-MX PHOSPHATE ALKALINE SOLUTION, 0.25%: 2021-10-29