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17α-hydroxyprogesterone (17α-OHP) ELISA

EUDAMEDFDA UDIFDA 510(k)

Class IVD General (EU MDR)

Ref CAN-P-400Model 96 Tests510(k) K832297

by Diagnostics Biochem Canada Inc.

Identity

Trade Name
DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA FDA UDI
Generic Name
17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
17α-hydroxyprogesterone (17α-OHP) ELISA EUDAMED
For the quantitative measurement of 17α-Hydroxyprogesterone (17α-OHP) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
Model / Reference
96 Tests EUDAMED
CAN-P-400 EUDAMEDFDA UDI
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. FDA UDI

Identifiers

Catalog Number
CAN-P-400 FDA UDI
Primary DI / UDI-DI
++B261CANP400FJ EUDAMED
B261CANP4000 FDA UDI
Basic UDI-DI
B-++B261CANP400FJ EUDAMED
FDA Product Code
JLX FDA UDI
EMDN Code
W0102050107 17 OH PROGESTERONE EUDAMED
GMDN Term
17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.1395 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

17α-hydroxyprogesterone (17α-OHP) ELISA by Diagnostics Biochem Canada Inc — Class IVD General — IVDD, FDA_510K — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Active

FDA_510K

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Diagnostics Biochem Canada Inc.
EUDAMED SRN
CA-MF-000032449
FDA Applicant
Diagnostics Biochem Canada, Inc.
Authorised Representative
MedEnvoy Global BV NL-AR-000024028

Sources (3)

  • EUDAMED 1f8287c4-c0f0-4a90-b4f9-2f7f420bfb74 85 fields · synced Jun 18, 2026
  • FDA UDI 1726949e-93bc-4b45-b16e-37c65a7c63f7 36 fields · synced May 30, 2026
  • FDA 510(k) K832297 1 fields · synced May 18, 2026