DEVICE: Histofluor® Rodent LKS Fluorescent Antibody Test System (M7491200805101)
Device Identifier (DI) Information
Histofluor® Rodent LKS Fluorescent Antibody Test System
12008-05 (10)
Not in Commercial Distribution
12008-05 (10)
IMMUNO CONCEPTS INC
12008-05 (10)
Not in Commercial Distribution
12008-05 (10)
IMMUNO CONCEPTS INC
Rat KS 8 Well Tissue Slides - 10 Slides
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| 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? |
|---|---|---|---|---|
| 55075 | Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to intrinsic factor and/or parietal cells in a clinical specimen, using a fluorescent immunoassay method. It is typically used to aid in the diagnosis of conditions associated with deficiencies in intrinsic factor and/or parietal cell function/production such as autoimmune gastric disorders (e.g., pernicious anaemia, chronic atrophic gastritis), funicular myelosis, and various autoimmune endocrinopathies.
|
Active | false |
| 55147 | Smooth muscle antibody IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to smooth muscle in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
| 55022 | Liver-kidney microsome 1 antibody (anti-LKM1) IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to liver-kidney microsome 1 protein (anti-LKM1) in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
| 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 |
| 55031 | Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antibodies to mitochondria M2 (anti-Mi2) in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| No Product Codes | |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
0044f7a2-a3ed-4495-83c9-4c142cbddfdd
June 06, 2025
5
September 24, 2016
June 06, 2025
5
September 24, 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
[?]
No Customer Contact currently defined