Standard Rabbit Complement, Frozen

Basic Information

• Brand Name: Standard Rabbit Complement, Frozen
• Primary DI: 06284510990073
• Version / Model: CL3005
• Catalog Number: CL3005
• Company Name: Cedarlane Corporation
• Labeler DUNS: 243928822
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: 9071b3f9-8573-47ce-8736-efec33d7387f

Device Description

Standard Rabbit Complement is derived from a pool of normal rabbit serum. It contains no other additives or preservatives.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTQ	Reagent, Complement	Immunology	866.4100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58366	Complement reagent IVD	A solution containing complement proteins intended to be used alone or in combination with other IVDs in the processing, staining and/or testing of clinical laboratory specimens. Typical uses may include HLA tissue typing by a complement-dependent cytotoxicity (CDC) method, or antigen-antibody based reactions by complement fixation test (CFT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06284510990073	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	25	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -70 – -70 Degrees Celsius