AccessGUDID - DEVICE: BIOCLONE (10758750003600)

GUDID

Device Identifier (DI) Information

Brand Name: BIOCLONE
Version or Model: 716910
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 716910
Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.

Primary DI Number: 10758750003600
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068715424 *Terms of Use

Device Description: Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML Green

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
46949	Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination	A collection of immunoglobulins capable of binding to individual classes of human immunoglobulin and/or complement components fixed to red blood cell antigens, and intended to be used together in testing a clinical specimen to detect red blood cell sensitization by specific molecules, using an agglutination technique. The specific molecules intended to be detected may include immunoglobulin A (IgA), immunoglobulin G (IgG), immunoglobulin M (IgM), C3c, and/or C3d.	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c402e8f3-095e-4102-aadf-a2696e9d30df
Public Version Date: April 24, 2025
Public Version Number: 7
DI Record Publish Date: October 22, 2014