Identity
- Trade Name
- Actim PROM Controls FDA UDI
- Generic Name
- Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, control FDA UDI
- Device Name
- The Actim PROM Controls kit consists of one of each of the following components: 1. Actim PROM Negative Control (0 μg/L) 2. Actim PROM Low Positive Control (40 μg/L) 3. Actim PROM High Positive Control (250 μg/L) 4. Actim Reconstitution Solution 5. Instructions for use FDA UDI
- Model / Reference
- 30800ETUS FDA UDI
- Description
- The Actim PROM Controls kit consists of one of each of the following components: 1. Actim PROM Negative Control (0 μg/L) 2. Actim PROM Low Positive Control (40 μg/L) 3. Actim PROM High Positive Control (250 μg/L) 4. Actim Reconstitution Solution 5. Instructions for use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430030990622 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, control 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, control
Actim PROM Controls by Actim Oy — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K123986 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Actim Oy
Sources (2)
- FDA UDI f76486d6-7dac-4cef-873f-96d8d2d4dcab 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026