FDA UDI
In Commercial Distribution
🇺🇸 United States
RAMP® CK-MB TEST KIT; 25 TESTS
DI: 10627966005015
·
Model: C1102
·
Response Biomedical Corp
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RAMP® CK-MB TEST KIT; 25 TESTS
- Primary DI
- 10627966005015
- Version / Model
- C1102
- Catalog Number
- C1102
- Company Name
- Response Biomedical Corp
- Labeler DUNS
- 248609018
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 5
- Public Version Date
- 2025-11-14
- Public Version Status
- Update
- Public Device Record Key
- 4da1d356-c993-40d9-b071-2ab964c0e6c2
Device Description
The RAMP® CK-MB test is a quantitative immunochromatographic test for the determination of CK-MB in EDTA whole blood.
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 |
|---|---|---|---|---|
| JHX | Fluorometric Method, Cpk Or Isoenzymes | Clinical Chemistry | 862.1215 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52995 | Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10627966005015 | GS1 |
Customer Contacts
- Phone
- +1.888.525.7267
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033747 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | One test kit with 25 pouches, each containing 1 RAMP® test cartridge and 1 test tip, and 25 RAMP® buffer vials |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at 2 to 8°C (35 to 46°F). Do not freeze.