AccessGUDID - DEVICE: Anti-C3b,-C3d (Murine Monoclonal) Gamma-clone (10888234000402)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-C3b,-C3d (Murine Monoclonal) Gamma-clone
Version or Model: 0004068
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0004068
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234000402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: This reagent is used in direct antiglobulin tests where the detection of C3 (as C3b or C3d) is required. This product configuration is a single vial.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
52721	Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody	One or multiple immunoglobulins capable of binding to C3b and/or C3d complement components fixed to red blood cells, and intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by complement C3b and/or C3d, using an agglutination technique.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: between 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b63a2a93-aa01-4ec0-886b-a10e29422d56
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 04, 2016