AccessGUDID - DEVICE: ARCHITECT (00380740011185)

GUDID

Device Identifier (DI) Information

Brand Name: ARCHITECT
Version or Model: 6L27-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06L2725
Company Name: Abbott GmbH & Co. KG

Primary DI Number: 00380740011185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315786293 *Terms of Use

Device Description: ARCHITECT HAVAB-G Reagent Kit

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
Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the Hepatitis A virus in a clinical specimen, using a chemiluminescent immunoassay method.

FDA Product Code

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Product Code	Product Code Name
MJY	KIT, SEROLOGICAL, NEGATIVE CONTROL
JIS	CALIBRATOR, PRIMARY
LOL	Hepatitis a test (antibody and igm antibody)
MJX	KIT, SEROLOGICAL, POSITIVE CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113704	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

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 194576e6-0b30-4315-a0ab-57ad5ed1c3d3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016