AccessGUDID - DEVICE: ARCHITECT (00380740013110)

GUDID

Device Identifier (DI) Information

Brand Name: ARCHITECT
Version or Model: 7F93-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07F9301
Company Name: ABBOTT LABORATORIES

Primary DI Number: 00380740013110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079226220 *Terms of Use

Device Description: Tobramycin Calibrators

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
Tobramycin 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 the antimicrobial drug tobramycin in a clinical specimen.

FDA Product Code

[?]

Product Code	Product Code Name
DLJ	CALIBRATORS, DRUG SPECIFIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K872349	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 8 Degrees Celsius
Special Storage Condition, Specify: Do not freeze calibrators.
Handling Environment Temperature: less than 29 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a6a6f62b-221c-4810-ae4b-a02b61e4ed9f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 06, 2016