DEVICE: O. Tsutsugamushi(Scrub Typhus) 12 well; 10 pk (00813545026066)

Device Identifier (DI) Information

O. Tsutsugamushi(Scrub Typhus) 12 well; 10 pk
I-OTS01X
In Commercial Distribution
I-OTS01X
SCIMEDX CORPORATION
00813545026066
GS1

1
155424708 *Terms of Use
No description.
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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?
51416 Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Orientia tsutsugamushi in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Orientia tsutsugamushi, the rickettsial bacteria associated with scrub typhus.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LSQ Reagent, Rickettsia Serological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

816eacd3-6f2e-4d69-b6ee-06c7ca8a64d1
August 09, 2021
3
September 21, 2016
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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
No Package DIs found
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
18002215598
service@scimedx.com
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