DEVICE: FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link) (05700571106907)

Device Identifier (DI) Information

FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link)
IR084
In Commercial Distribution

AGILENT TECHNOLOGIES, INC.
05700571106907
GS1

1
084963177 *Terms of Use
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a Clone EP1 Ready-to-Use (Link)
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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
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FDA Product Code

[?]
Product Code Product Code Name
MYA IMMUNOHISTOCHEMISTRY ANTIBODY ASSAY, ESTROGEN RECEPTOR
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K120663 000
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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: 40-60 Tests
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Device Record Status

447ce70e-fd24-4ca5-8993-f08a7cd7ae8d
July 26, 2021
7
September 16, 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
No
No CLOSE

Customer Contact

[?]
+1-805-566-6655
dako.usregulatory@agilent.com
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