DEVICE: ARCHITECT (00380740014254)

Device Identifier (DI) Information

ARCHITECT
7K63-01
In Commercial Distribution
07K6301
ABBOTT IRELAND
00380740014254
GS1

1
989964119 *Terms of Use
ARCHITECT Free T3 Calibrators
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38261 Free triiodothyronine (FT3) IVD, calibrator
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of free triiodothyronine (FT3) in a clinical specimen.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CDP RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
JIT CALIBRATOR, SECONDARY
JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

f877a8a4-c7a9-4ef2-b8d8-7bd122794a04
February 21, 2024
4
September 09, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)422-2688
xx@xx.xx
CLOSE