DEVICE: Mono Mo A-Hu Neurofilament Protein Cl 2F11 (05700572027973)

Device Identifier (DI) Information

Mono Mo A-Hu Neurofilament Protein Cl 2F11
M0762
In Commercial Distribution

AGILENT TECHNOLOGIES SINGAPORE PTE LTD
05700572027973
GS1
September 21, 2026
1
894671143 *Terms of Use
Monoclonal Mouse Anti-Human Neurofilament Protein Clone 2F11
CLOSE

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?
57481 Neurofilament protein 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 neurofilament protein [e.g., neurofilament light protein (NF-L), neurofilament protein M (NF-M) and/or neurofilament heavy protein (NF-H)] in a clinical specimen.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NJT IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Total Volume: 0.2 Milliliter
CLOSE

Device Record Status

2d0026d9-51d4-4a9a-b2fa-89efda40d10c
August 02, 2024
3
September 17, 2020
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1-800-227-9770
Global.RA@agilent.com
CLOSE