Device
For the quantitative measurement of 17α-hydroxyprogesterone (17α-OHP) in human serum by an ELISA (enzyme-linked immunosorbent assay).
Manufacturer
Diagnostics Biochem Canada Inc
Diagnostics Biochem Canada Inc
Model: CAN-P-540
Catalog: CAN-P-540
DI: B261CANP5400
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
For the quantitative measurement of 17α-hydroxyprogesterone (17α-OHP) in human serum by an ELISA (enzyme-linked immunosorbent assay).
For in vitro diagnostic use.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
71c15441-907b-4ccf-8485-5d90843405c4
Distribution Status:
In Commercial Distribution
DUNS Number:
207718438
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B261CANP5400
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 63577
Name: 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)
Definition:
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).
FDA Product Codes
JLX
Radioimmunoassay, 17-Hydroxyprogesterone
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
8
Storage Handling - Storage Handling Type:
Storage Environment Temperature