AccessGUDID - DEVICE: ARCHITECT (00380740101220)

GUDID

Device Identifier (DI) Information

Brand Name: ARCHITECT
Version or Model: 5P04-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05P0401
Company Name: ABBOTT LABORATORIES

Primary DI Number: 00380740101220
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079226220 *Terms of Use

Device Description: TDM Multiconstituent Calibrator

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multiple-therapy therapeutic drug monitoring IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.

FDA Product Code

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Product Code	Product Code Name
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE

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

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Storage and Handling
Handling Environment Temperature: less than 29 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b883f275-620c-4a64-bbdd-b6c4c3ecbf17
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 06, 2016