AccessGUDID - DEVICE: BioPlex 2200 (00847865012331)

GUDID

Device Identifier (DI) Information

Brand Name: BioPlex 2200
Version or Model: SW4.1_V2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6651170D
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847865012331
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 884513334 *Terms of Use

Device Description: ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2

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:	No
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?
54810	Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple types of antinuclear antibodies (ANA) in a clinical specimen, using a multiplex method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LLL	EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL
LKJ	ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
LJM	ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS
MQA	ANTI-RIBOSOMAL P ANTIBODIES
LKO	ANTI-RNP ANTIBODY, ANTIGEN AND CONTROL
LRM	ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 Each

Device Record Status

Public Device Record Key: 8cd2a1ee-6e56-4d02-bd86-15b082d85374
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 12, 2016

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

Secondary DI

[?]

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

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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