DEVICE: QIAGEN Proteinase K (04053228002758)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
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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? |
|---|---|---|---|---|
| 62498 | PCR/NAT protease reagent IVD |
A substance or reactant intended to be used as a proteolytic enzyme (e.g., proteinase K) to digest proteins in a clinical specimen. It is used to aid in the extraction of nucleic acids for subsequent analysis using a nucleic acid technique (NAT) [e.g., polymerase chain reaction (PCR), in situ hybridization (ISH)].
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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
d2fbf59e-a8f2-43a9-9f0d-811cf6cf6576
March 29, 2018
2
August 15, 2017
March 29, 2018
2
August 15, 2017
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