DEVICE: FLEX Mono Mo A-Hu Progesterone Receptor Clone PgR 636 RTU (Link) (05700571101759)
Device Identifier (DI) Information
FLEX Mono Mo A-Hu Progesterone Receptor Clone PgR 636 RTU (Link)
IR068
In Commercial Distribution
AGILENT TECHNOLOGIES, INC.
IR068
In Commercial Distribution
AGILENT TECHNOLOGIES, INC.
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor Clone PgR 636 Ready-to-Use (Link)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
57210 | Estrogen (oestrogen)/progesterone receptor IVD, antibody |
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of estrogen (oestrogen) and/or progesterone receptors in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MXZ | Immunohistochemistry assay,antibody,progesterone receptor |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K130861 | 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: 40-60 Tests |
Device Record Status
17df6b07-deaf-4284-b05d-b78784ab4951
July 26, 2021
7
January 03, 2017
July 26, 2021
7
January 03, 2017
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
[?]
+1-805-566-6655
dako.usregulatory@agilent.com
dako.usregulatory@agilent.com