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.
00608337000108
GS1

1
114152184 *Terms of Use
No description.
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MVZ System,Test,Home,Hiv-1
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BP910001 002
BP910001 004
BP910001 006
BP910001 008
BP910001 010
BP910001 016
BP910001 017
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 18 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

05766948-2075-4145-ab94-aa2b1935ca84
July 22, 2021
6
September 05, 2014
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
610-882-1820
customercare@orasure.com
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