AccessGUDID - DEVICE: Low-Tox-H Rabbit Complement (06284510990172)

GUDID

Device Identifier (DI) Information

Brand Name: Low-Tox-H Rabbit Complement
Version or Model: CL3305
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CL3305
Company Name: Cedarlane Corporation

Primary DI Number: 06284510990172
Issuing Agency: GS1
Commercial Distribution End Date: December 05, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 243928822 *Terms of Use

Device Description: Low-Tox-H Rabbit Complement, Frozen

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTQ	Reagent, Complement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: exactly -70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: bce60281-49f2-4e91-aad3-a46e5c4732ee
Public Version Date: December 13, 2024
Public Version Number: 2
DI Record Publish Date: December 08, 2022