DEVICE: OraSure HIV-1 Oral Specimen Collection Device (00608337000108)
Device Identifier (DI) Information
OraSure HIV-1 Oral Specimen Collection Device
HIV-1 Oral Specimen Collection Device
In Commercial Distribution
Orasure Technologies, Inc.
HIV-1 Oral Specimen Collection Device
In Commercial Distribution
Orasure Technologies, Inc.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
61164 | Oral/upper respiratory tract specimen collection kit |
A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MVZ | System,Test,Home,Hiv-1 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
BP910001 | 002 |
BP910001 | 004 |
BP910001 | 006 |
BP910001 | 008 |
BP910001 | 010 |
BP910001 | 016 |
BP910001 | 017 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 18 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
05766948-2075-4145-ab94-aa2b1935ca84
July 22, 2021
6
September 05, 2014
July 22, 2021
6
September 05, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20608337000102 | 500 | 00608337000108 | In Commercial Distribution | carton | |
10608337000105 | 50 | 00608337000108 | In Commercial Distribution | carton |
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
[?]
610-882-1820
customercare@orasure.com
customercare@orasure.com