DEVICE: AmpliVue (30014613312093)
Device Identifier (DI) Information
AmpliVue
Bordetella Assay
Not in Commercial Distribution
M209
QUIDEL CORPORATION
Bordetella Assay
Not in Commercial Distribution
M209
QUIDEL CORPORATION
AmpliVue Bordetella Assay
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
50505 | Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple species of Bordetella bacteria, which may include B. pertussis, B. parapertussis and/or B. bronchiseptica in a clinical specimen, using a nucleic acid technique (NAT).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OZZ | Bordetella pertussis dna assay system |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
06bc7dfa-992a-420d-b525-03e7ffe36811
July 06, 2023
4
September 15, 2016
July 06, 2023
4
September 15, 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(858)552-1100
technicalsupport@quidel.com
technicalsupport@quidel.com