DEVICE: ARCHITECT (00380740003302)

Device Identifier (DI) Information

ARCHITECT
2K43-25
In Commercial Distribution
02K4325
ABBOTT LABORATORIES
00380740003302
GS1

1
079226220 *Terms of Use
ARCHITECT STAT Myoglobin Reagent Kit
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
Myoglobin IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the quantitative measurement of myoglobin in a clinical specimen, using a chemiluminescent immunoassay method.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JIS CALIBRATOR, PRIMARY
DDR MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

c7d7240b-de46-4079-90a6-75c45f7b224c
March 29, 2018
2
June 06, 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