DEVICE: ImmunoRetriever 20X with EDTA (B502BSB00320)
Device Identifier (DI) Information
ImmunoRetriever 20X with EDTA
1000 ml
In Commercial Distribution
BSB 0032
BIO SB, INC.
1000 ml
In Commercial Distribution
BSB 0032
BIO SB, INC.
ImmunoDNA Retriever EDTA is a concentrate used with heat-induced epitope or nucleic acid retrieval procedures for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH).
Device Characteristics
MR Safe | |
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? |
---|---|---|---|---|
57767 | Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PPM | General Purpose Reagent |
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
814dcd3b-0149-408f-a844-cdf2fb3e29c1
September 08, 2020
1
August 31, 2020
September 08, 2020
1
August 31, 2020
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