AccessGUDID - DEVICE: RHEUMATEX® (10859035006009)

GUDID

Device Identifier (DI) Information

Brand Name: RHEUMATEX®
Version or Model: 34S2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALERE NORTH AMERICA, LLC

Primary DI Number: 10859035006009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 826027364 *Terms of Use

Device Description: No description.

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:	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?
54846	Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple antibodies associated with rheumatoid arthritis in a clinical specimen, using a multiplex method. The assayed antibodies may include autoimmune antibodies directed at rheumatoid factor (RF) and/or cyclic citrullinated peptide.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DHR	System, Test, Rheumatoid Factor

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: eb00113a-ca0e-411f-8da6-f3d3cbabb46f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 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: 00859035006002 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-877-441-7440
Email: TS.SCR@alere.com

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