DEVICE: IMMCO DIAGNOSTICS (00845714000881)
Device Identifier (DI) Information
IMMCO DIAGNOSTICS
1103-240X
In Commercial Distribution
1103-240X
IMMCO DIAGNOSTICS, INC.
1103-240X
In Commercial Distribution
1103-240X
IMMCO DIAGNOSTICS, INC.
Hep-2 Cells -Anti-Nuclear Antibody IFA Kit
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
54808 | Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LKJ | Antinuclear Antibody, Antigen, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K883883 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 240 DETERMINATIONS |
Device Record Status
528cf532-93c4-406a-a33a-d3e342e79299
July 06, 2018
3
September 21, 2016
July 06, 2018
3
September 21, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-537-8378
INFO@IMMCO.COM
INFO@IMMCO.COM