DEVICE: ARCHITECT (00380740011369)

Device Identifier (DI) Information

ARCHITECT
6L45-21
In Commercial Distribution
06L4521
ABBOTT LABORATORIES
00380740011369
GS1

1
079226220 *Terms of Use
Total Bilirubin
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Total bilirubin IVD, kit, spectrophotometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of total bilirubin in a clinical specimen, using a spectrophotometry method.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CIG DIAZO COLORIMETRY, BILIRUBIN
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
Special Storage Condition, Specify: Keep protected from light.
Handling Environment Temperature: less than 29 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

3b804a35-ad3e-4579-983a-b2c4bb9d041e
March 29, 2018
2
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