AccessGUDID - DEVICE: BioPlex 2200 (00847865000086)

GUDID

Device Identifier (DI) Information

Brand Name: BioPlex 2200
Version or Model: 6651150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6651150
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847865000086
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 Reagent pack

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	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
LKO	ANTI-RNP ANTIBODY, ANTIGEN AND CONTROL
MQA	ANTI-RIBOSOMAL P ANTIBODIES
LRM	ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL
LLL	EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL
LJM	ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS
LKJ	ANTINUCLEAR ANTIBODY, 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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 100 Tests

Device Record Status

Public Device Record Key: c61eb2d3-e53c-47bc-87e9-93909b61702e
Public Version Date: July 29, 2021
Public Version Number: 5
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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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