DEVICE: IMMCO DIAGNOSTICS (00845714003035)
Device Identifier (DI) Information
IMMCO DIAGNOSTICS
2107X
In Commercial Distribution
2107X
IMMCO DIAGNOSTICS, INC.
2107X
In Commercial Distribution
2107X
IMMCO DIAGNOSTICS, INC.
IgA FITC Conjugate
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
43486 | Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD |
One or multiple immunoglobulins sourced from an animal (e.g., goat, sheep, mouse, rabbit) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin A (IgA) antibodies. The immunoglobulin molecules are conjugated or bound by additional substances (e.g., fluorescent markers, peroxidase enzymes) for the detection of immune complexes in clinical specimens.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K060157 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 5 ml |
Device Record Status
8797f224-8407-4a12-bc5b-ab87188b60ef
March 08, 2022
4
September 23, 2016
March 08, 2022
4
September 23, 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