DEVICE: Fresh Cells (30014613335603)
Device Identifier (DI) Information
Fresh Cells
C49-0102A
In Commercial Distribution
C49-0102A
DIAGNOSTIC HYBRIDS, INC.
C49-0102A
In Commercial Distribution
C49-0102A
DIAGNOSTIC HYBRIDS, INC.
CITES KIDNEY RHESUS SV W/C AN
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Cell culture line IVD | A cell line of known origin intended to be used alone or in combination with other IVDs, for cytogenetic analyses and/or for the detection/cultivation of viruses present in clinical laboratory specimens. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KIR | CELLS, ANIMAL AND HUMAN, CULTURED |
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
7fea072d-1637-4815-ad7f-371839358aab
October 22, 2018
1
September 21, 2018
October 22, 2018
1
September 21, 2018
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
[?]
+1(858)552-1100
technicalsupport@quidel.com
technicalsupport@quidel.com