DEVICE: DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA (B261CANP5400)

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Device Record History
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Device Identifier (DI) Information
DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA
CAN-P-540
In Commercial Distribution
CAN-P-540
Diagnostics Biochem Canada Inc
B261CANP5400
HIBCC

1
207718438 *Terms of Use
For the quantitative measurement of 17α-hydroxyprogesterone (17α-OHP) in human serum by an ELISA (enzyme-linked immunosorbent assay). 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?
63577 17-Hydroxyprogesterone 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 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of congenital adrenal hyperplasia (CAH).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JLX Radioimmunoassay, 17-Hydroxyprogesterone
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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

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

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Size Type Text
No Device Sizes
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Device Record Status
71c15441-907b-4ccf-8485-5d90843405c4
May 05, 2026
1
April 27, 2026
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

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