AccessGUDID - DEVICE: BioPlex 2200 (00847865000147)

Skip to Main Content

GUDID

View all sections | Close all sections

Device Identifier (DI) Information

Brand Name: BioPlex 2200
Version or Model: 6631230
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6631230
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847865000147
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 884513334 *Terms of Use

Device Description: EBV IgG Control Set

CLOSE

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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
49660	Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Epstein-Barr virus (EBV) in a clinical specimen.	Active	false
49680	Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the Epstein-Barr virus nuclear antigen (EBNA) of Epstein-Barr virus (EBV) in a clinical specimen.	Obsolete	false
49686	Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the early antigen (EA) of Epstein-Barr virus (EBV) in a clinical specimen.	Obsolete	false

CLOSE

FDA Product Code

Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

CLOSE

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

CLOSE

Storage and Handling

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

CLOSE

Clinically Relevant Size

Size Type Text
Device Size Text, specify: 4 Vials
Total Volume: 1.5 Milliliter

CLOSE

Device Record Status

Public Device Record Key: 1c1e7591-a6a8-4355-9b11-9fd91afe9c36
Public Version Date: February 21, 2019
Public Version Number: 4
DI Record Publish Date: September 12, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

CLOSE

Secondary DI

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

CLOSE

Unit of Use DI

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

Phone: +1(800)224-6723
Email: TechSupport.USSD@bio-rad.com

CLOSE

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES