DEVICE: IMMCO DIAGNOSTICS (00845714003035)

Device Identifier (DI) Information

IMMCO DIAGNOSTICS
2107X
In Commercial Distribution
2107X
IMMCO DIAGNOSTICS, INC.
00845714003035
GS1

1
079935300 *Terms of Use
IgA FITC Conjugate
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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
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FDA Product Code

[?]
Product Code Product Code Name
MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K060157 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 5 ml
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Device Record Status

8797f224-8407-4a12-bc5b-ab87188b60ef
March 08, 2022
4
September 23, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1-800-537-8378
INFO@IMMCO.COM
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