Kallestad 29403

GUDID 00847817016103

Kallestad Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Ethanol IFA

BIO-RAD LABORATORIES, INC.

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

• Primary Device ID: 00847817016103
• NIH Device Record Key: b3438cb1-1837-4871-a314-523fbf8b9fb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kallestad
• Version Model Number: 29403
• Catalog Number: 29403
• 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: true
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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	00847817016103 [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]

• 00847865001779: Kallestad FITC Conjugate
• 00847865001762: Kallestad FITC Conjugate
• 00847865001755: Kallestad Evans' Blue Counterstain
• 00847865001724: Kallestad Mouse Stomach/Kidney 8 Well Slides
• 00847865001717: Kallestad Mouse Stomach/Kidney 8 Well Slides
• 00847865001700: Kallestad Mouse Stomach/Kidney 8 Well Slides
• 00847865001694: Kallestad Mouse Stomach Kidney Substrate
• 00847865001687: Kallestad Patient Sample Diluent
• 00847865001670: Kallestad HEp-2 Cell Line 24 Well Slides
• 00847865001656: Kallestad HEp-2 Cell Line 12 Well Slides
• 00847865001649: Kallestad HEp-2 Cell Line 12 Well Slides
• 00847865001632: Kallestad HEp-2 Cell Line 12 Well Slides
• 00847865001625: Kallestad HEp-2 Cell Line 6 Well Slides
• 00847865001618: Kallestad HEp-2 Cell Line 6 Well Slides
• 00847865001601: Kallestad HEp-2 Cell Line Substrate
• 00847865001595: Kallestad HEp-2 Cell Line Substrate
• 00847865001588: Kallestad HEp-2 Cell Line Substrate
• 00847865001571: Kallestad Crithidia luciliae 8 Well Slides
• 00847865001564: Kallestad Crithidia luciliae 8 Well Slides
• 00847865001557: Kallestad Crithidia luciliae 4 Well Slides
• 00847865001540: Kallestad Crithidia luciliae 4 Well Slides
• 00847865001533: Kallestad Crithidia luciliae Substrate
• 00847865001526: Kallestad Crithidia luciliae Substrate
• 00847865001496: MONOFLUO Legionella pneumophila IFA Test Kit
• 00847865001205: Kallestad Mounting Media
• 00847817016271: Kallestad Anti-Tg (Thyroglobulin) Microplate EIA
• 00847817016257: Kallestad Anti-Mitochondrial Microplate EIA
• 00847817016240: Kallestad Anti-dsDNA Microplate EIA
• 00847817016110: Kallestad Sample Diluent, 60 mL
• 00847817016103: Kallestad Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Ethanol IFA
• 00847817008559: Kallestad Anti-TPO (Thyroid Peroxidase) Microplate EIA
• 00847817000294: Kallestad Anti-Cyclic Citrullinated Peptides (CCP) II Microplate EIA