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Actim PROM

FDA UDI

Class I (US FDA UDI)

by Actim Oy

Identity

Trade Name
Actim PROM FDA UDI
Generic Name
Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solution contains bovine serum albumin (BSA), protease inhibitors and preservatives. - One dipstick in a sealed aluminum foil pouch with desiccant. - One sterile polyester swab for specimen collection. FDA UDI
Model / Reference
30821ETUS FDA UDI
Description
Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solution contains bovine serum albumin (BSA), protease inhibitors and preservatives. - One dipstick in a sealed aluminum foil pouch with desiccant. - One sterile polyester swab for specimen collection. FDA UDI

Identifiers

Primary DI / UDI-DI
06430030990714 FDA UDI
510(k) Number
K123986 FDA UDI
FDA Product Code
OAM FDA UDI
GMDN Term
Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical

Actim PROM by Actim Oy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical.

Cleared under the same submission

K123986 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Actim Oy

Sources (1)

  • FDA UDI 7c9fad6a-4b68-4a70-9b02-8a929f7c9e57 35 fields · synced May 30, 2026