DEVICE: ARCHITECT (00380740011109)

Device Identifier (DI) Information

ARCHITECT
6L22-01
In Commercial Distribution
06L2201
Abbott GmbH & Co. KG
00380740011109
GS1

1
315786293 *Terms of Use
ARCHITECT CORE Calibrator
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
Hepatitis B virus core total antibody 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 total antibodies to the Hepatitis B virus core antigen in a clinical specimen.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LOM Test, hepatitis b (b core, be antigen, be antibody, b core igm)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P080023 001
P080023 002
P080023 003
P080023 006
P080023 008
No CLOSE

Sterilization

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

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

e7037d97-fabc-46dd-8753-ffe202caa0f5
July 06, 2018
3
January 30, 2015
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
xxx@xxx.xxx
CLOSE