AccessGUDID - DEVICE: ARCHITECT (00380740003555)

GUDID

Device Identifier (DI) Information

Brand Name: ARCHITECT
Version or Model: 2K91-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 02K9101
Company Name: ABBOTT LABORATORIES

Primary DI Number: 00380740003555
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 079226220 *Terms of Use

Device Description: ARCHITECT CA19-9XR 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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38225	Cancer antigen 19-9 (CA19-9) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of gastrointestinal and pancreatic cancer antigen 19-9 (CA19-9) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	CALIBRATOR, SECONDARY
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
NIG	SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052000	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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 78f3630e-480d-4a81-afe6-a6fd73742a96
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: June 06, 2016