DEVICE: Amplichek (00847661005926)
Device Identifier (DI) Information
Amplichek
12000201
In Commercial Distribution
12000201
BIO-RAD LABORATORIES, INC.
12000201
In Commercial Distribution
12000201
BIO-RAD LABORATORIES, INC.
Amplichek II Negative (A nucleic acid control.)
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? |
|---|---|---|---|---|
| 50838 | Clostridium difficile nucleic acid IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers, from Clostridium difficile bacteria [e.g., genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027), and genes encoding toxin A and/or B] in a clinical specimen and/or culture isolate.
|
Active | false |
| 51669 | MRSA nucleic acid IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid conferring methicillin resistance, in methicillin-resistant Staphylococcus aureus (MRSA) bacteria present in a clinical specimen and/or culture isolate.
|
Active | false |
| 50901 | Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid conferring vancomycin resistance, in vancomycin-resistant Enterococcus (VRE) bacteria isolated by culture from a clinical specimen.
|
Obsolete | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| PMN | Assayed external control material for microbiology nucleic acid amplification (NAT) assays |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| DEN150058 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
8875b14d-6ec8-478f-a12b-00e35c0cf3c3
July 29, 2021
6
September 19, 2016
July 29, 2021
6
September 19, 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 |
|---|---|
| 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(800)854-6737
qsd.techservice@bio-rad.com
qsd.techservice@bio-rad.com