AccessGUDID - DEVICE: ARCHITECT (00380740003326)

GUDID

Device Identifier (DI) Information

Brand Name: ARCHITECT
Version or Model: 2K44-10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 02K4410
Company Name: ABBOTT LABORATORIES

Primary DI Number: 00380740003326
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 079226220 *Terms of Use

Device Description: ARCHITECT CA15-3 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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38222	Cancer antigen 15-3 (CA15-3) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	CALIBRATOR, SECONDARY
MOI	SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042732	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: c3cd45d7-76e6-43be-82a2-df5221444416
Public Version Date: June 30, 2023
Public Version Number: 4
DI Record Publish Date: June 06, 2016