Kallestad ANCA 29401

GUDID 00847817016097

Kallestad pANCA Positive Control, 0.5 mL

BIO-RAD LABORATORIES, INC.

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

• Primary Device ID: 00847817016097
• NIH Device Record Key: cb3e0335-b944-4a54-b727-bfbca4d6dafb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kallestad ANCA
• Version Model Number: 29401
• Catalog Number: 29401
• Company DUNS: 884513334
• Company Name: BIO-RAD LABORATORIES, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD@bio-rad.com

Device Dimensions

• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817016097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982898

FDA Product Code

• MOB: TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-12

On-Brand Devices [Kallestad ANCA]

• 00847817022357: Kallestad ANCA IFA Formalin Fixed Slides, 5 x 6 Wells
• 00847817020162: Kallestad ANCA IFA Ethanol Fixed Slides 5 x 6 Wells
• 00847817016233: Kallestad ANCA IFA COMBI Slides, 5 x 6 + 6 Wells
• 00847817016219: Kallestad ANCA IFA Ethanol Fixed Slides, 5 x 12 Wells
• 00847817016196: Kallestad ANCA Blotting Paper, 10 x 12 Wells
• 00847817016189: Kallestad ANCA Blotting Paper, 10 x 6 Wells
• 00847817016172: Kallestad ANCA Coverslips, 12
• 00847817016165: Kallestad ANCA Phosphate Buffered Saline, 8.6 g
• 00847817016158: Kallestad ANCA Anti-Human IgG Conjugate, 5 mL
• 00847817016141: Kallestad ANCA Mounting Medium, 5 mL
• 00847817016134: Kallestad ANCA Evans Blue Counterstain, 1 mL
• 00847817016127: Kallestad ANCA Negative Control, 0.5 mL
• 00847817016097: Kallestad pANCA Positive Control, 0.5 mL
• 00847817016080: Kallestad cANCA Positive Control, 0.5 mL