FDA UDI
In Commercial Distribution
🇺🇸 United States
Actim PROM Controls
DI: 06430030990622
·
Model: 30800ETUS
·
Actim Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Actim PROM Controls
- Primary DI
- 06430030990622
- Version / Model
- 30800ETUS
- Company Name
- Actim Oy
- Labeler DUNS
- 368646046
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-28
- Public Version
- 3
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- f76486d6-7dac-4cef-873f-96d8d2d4dcab
Device 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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAM | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | Clinical Chemistry | 862.1550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42194 | Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of insulin-like growth factor binding protein 1 (IGFBP-1) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430030990622 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123986 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius