2020 West McNab Road, Suite 118, Fort Lauderdale, FL 33309
Call today for a quote:  (954) 415-2700
This page was last updated: January 25, 2012
January 25, 2012:  UPDATED AND NEW INVENTORY PAGES ARE AVAILABLE.
NEW ITEMS:  Multi-Test Samples
for ANA, Hepatitis, Liver, Kidney, Lipids, Iron and EBV
Quality
Extensive Specimen Inventory

Complex Antibodies, Inc. meets the regulatory requirements for your specimen collections.  Our extensive selection of diagnostic remnant specimens is collected under IRB approved collection protocols.  Protection of human subjects is our utmost concern. These samples are de-identified and are not traceable back to the subject.   Individual identifiable health information is not provided.  Information provided with the specimen includes a unique Identification number, age, gender, collection date, matrix, volume, test value if applicable, and viral testing if available.

Complex Antibodies,Inc.can also provide bulk material for your projects.  Bulk material collected under Informed Consent can also be obtained. 

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Quality Management System

Complex Antibodies, Inc. utilizes ISOXpress Document Control and Quality System software to ensure and maintain compliance with 21 CFR 820 and ISO 13485 regulations.  Processes are automated for:

  • Document Control
  • CAPA and NCMR
  • Internal Auditing
  • Management Review
  • Supplier Management
  • Customer Complaints
  • Employee Training
  • Equipment QA/QC

We are very proud to mention the following audits/inspection results:

  • FDA Inspection conducted in November 2009:  no 483 issued.
  • Audited by one of the largest U.S. diagnostic manufacturers in September 2010:  CAI received an "A" supplier rating.

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Freezer Inventory Software and Temperature Monitoring System

Complex Antibodies, Inc. utilizes Freezerworks™ Inventory and Sample Tracking software for managing all specimen storage.  Freezerworks™ software meets GLP and FDA guidelines, including 21 CFR 11 compliance.  Specimen types can be searched easily and reported in user-defined formats.  Quality assurance mechanisms are in place to eliminate errors such as missing data upon entry or duplicate ID issues.





In addition to the inventory software, our freezers are temperature monitored 24 hours a day, seven day a week via the Refrigerator/Freezer Guard from Temperature Guard Microtechnologies, Inc. The Refrigerator/Freezer Guard is an NIST Traceable Certified monitoring system.  Data is captured in the software program providing daily and monthly logs, trending information, and event logs.  The system notifies administration and other designated individuals via email and/or by phone if a unit is out of the acceptable temperature range, or if there has been a power failure. 

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Unique Collections/Projects Managed to Specifications

Here are a few examples of unique specimen collections that Complex Antibodies, Inc. can assist you with:

  • Collections done under Informed Consent.  Case Report Forms (CRF's) can be developed by CAI or your company CRF can be utilized.
  • Multiple matrix collections (bulk matched sets) from whole blood donors
  • Endogenous Interfering Substance products: hemoglobin, triglycerides, bilirubin (direct and indirect)
  • Stability studies

Please visit our Other Products page for more information.

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