DEVICE: Antiserum to Human Properdin (B1761080)
Device Identifier (DI) Information
Antiserum to Human Properdin
1
In Commercial Distribution
108002
KENT LABORATORIES INC
1
In Commercial Distribution
108002
KENT LABORATORIES INC
Goat antiserum to human Properdin
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? |
---|---|---|---|---|
58366 | Complement reagent IVD |
A solution containing complement proteins intended to be used alone or in combination with other IVDs in the processing, staining and/or testing of clinical laboratory specimens. Typical uses may include HLA tissue typing by a complement-dependent cytotoxicity (CDC) method, or antigen-antibody based reactions by complement fixation test (CFT).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DHL | Protein, Complement, Antigen, Antiserum, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
70fd882d-acc9-4a80-8e3d-375fe97d4bdd
September 12, 2018
3
September 24, 2016
September 12, 2018
3
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 |
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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