DEVICE: DBC Free Testosterone ELISA (B261CANFTE2600)

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Device Record History
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Device Identifier (DI) Information
DBC Free Testosterone ELISA
CAN-FTE-260
In Commercial Distribution
CAN-FTE-260
Diagnostics Biochem Canada Inc
B261CANFTE2600
HIBCC

1
207718438 *Terms of Use
For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use.
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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?
54181 Free testosterone IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free testosterone in a clinical specimen, using an enzyme immunoassay (EIA) method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K030730 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
6b826698-33ad-4ee2-917a-3449c6fbf7e7
May 03, 2023
2
November 10, 2022
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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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
1-519-681-8731
dbc@dbc-labs.com
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