IMMCO DIAGNOSTICS 1103-240

GUDID 00845714000874

Hep-2 Cells -Anti-Nuclear Antibody IFA Kit

IMMCO DIAGNOSTICS, INC.

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

• Primary Device ID: 00845714000874
• NIH Device Record Key: d69279f4-448a-48a2-9636-f311bc61be83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMCO DIAGNOSTICS
• Version Model Number: 1103-240
• Catalog Number: 1103-240
• Company DUNS: 079935300
• Company Name: IMMCO DIAGNOSTICS, 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-573-8378
• Email: INFO@IMMCO.COM

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845714000874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883883

FDA Product Code

• LKJ: Antinuclear Antibody, Antigen, Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [IMMCO DIAGNOSTICS]

• 00845714004391: Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit
• 00845714004384: Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit
• 00845714004353: Serum Diluent
• 00845714004339: Buffer Diluent
• 00845714004322: Buffer Diluent
• 00845714004315: Serum Diluent
• 00845714004308: Phosphate Buffered Saline
• 00845714004247: WASH BUFFER
• 00845714004193: Coverslips
• 00845714004179: Mounting Medium
• 00845714004162: Mounting Medium
• 00845714004001: cANCA Positive Control
• 00845714003974: ARA Positive Control
• 00845714003967: EMA (IgG) Positive Control
• 00845714003943: EMA Positive Control
• 00845714003851: pANCA Positive Control
• 00845714003776: cANCA Slide ethanol fixed
• 00845714003769: cANCA Slide
• 00845714003752: cANCA Slide
• 00845714003714: Pemphigold Positive
• 00845714003707: Pemphigus Foliaceus Control
• 00845714003677: nDNA Positive Control
• 00845714003660: Pemphigus Vulgaris Positive Control
• 00845714003653: Rat Kidney Slide
• 00845714003646: Primate Smooth Muscle Slide
• 00845714003608: Primate Esophagus (Distal) Slide
• 00845714003592: Primate Esophagus (Distal) Slide
• 00845714003585: Primate Esophagus Slide
• 00845714003578: Primate Esophagus (Distal) Slide
• 00845714003561: Primate Esophagus Slide
• 00845714003554: Primate/Guinea Pig Esophagus Slide
• 00845714003547: Mouse Kidney/Stomach/Liver Slide
• 00845714003530: Hep-2 Cells Slide
• 00845714003479: IgG FITC Conjugate
• 00845714003462: Coverslips
• 00845714003448: Mouse Kidney Slide
• 00845714003387: pANCA Slide
• 00845714003370: c+p ANCA COMBI Slide
• 00845714003363: Hep-2/Mouse Kidney/Stomach Slide
• 00845714003332: Hep-2/Mouse Kidney Slide
• 00845714003318: Negative Control
• 00845714003257: Intercellular Positive
• 00845714003240: Crithidia Luciliae Slide
• 00845714003233: Hep-2 Cells Slide
• 00845714003226: Hep-2 Cells Slide
• 00845714003223: Hep-2 Cells Slide
• 00845714003066: IgA/IgG FITC Conjugate w/EB
• 00845714003059: IgA/IgG FITC Conjugate
• 00845714003035: IgA FITC Conjugate
• 00845714003011: IgG FITC Conjugate