AccessGUDID - DEVICE: ARCHITECT (00380740003647)

GUDID

Device Identifier (DI) Information

Brand Name: ARCHITECT
Version or Model: 2K98-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02K9810
Company Name: ABBOTT LABORATORIES

Primary DI Number: 00380740003647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079226220 *Terms of Use

Device Description: Microalbumin Controls

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

[?]

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

GMDN Preferred Term Name	GMDN Definition
Microalbumin IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen.

FDA Product Code

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Product Code	Product Code Name
JIS	CALIBRATOR, PRIMARY
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
JIQ	TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030320	000

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 10 Degrees Celsius
Special Storage Condition, Specify: Do not freeze.
Handling Environment Temperature: less than 29 Degrees Celsius
Handling Environment Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ab10404-dfcf-4a8b-b4c3-ad6b3c4513e9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016