DEVICE: ZAPR™ (G507ZAPR01000)
Device Identifier (DI) Information
ZAPR™
ZAPR0100
In Commercial Distribution
ZAPR0100
Incell Corporation, LLC
ZAPR0100
In Commercial Distribution
ZAPR0100
Incell Corporation, LLC
Red Blood Cell Lysing Buffer
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
61165 | Blood cell lysis reagent IVD |
A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GGK | Products, Red-Cell Lysing Products |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 10 and 32 Degrees Celsius |
Storage Environment Temperature: between 10 and 32 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 100 Milliliter |
Device Record Status
677f4e43-067d-4c8d-9119-ad389e658c59
September 14, 2023
1
September 06, 2023
September 14, 2023
1
September 06, 2023
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
[?]
800-364-1765
info@incell.com
info@incell.com