Identity
- Trade Name
- RAMP® CK-MB TEST KIT; 25 TESTS FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- C1102 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10627966005015 FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical FDA UDI
- Models / Variants
- Ramp® Ck-Mb Test Kit FDA UDI25 Tests FDA UDI
Classification
- 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: Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical
Ramp® Ck-Mb Test Kit +1 more model by Response Biomedical Corp — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Response Biomedical Corp
Sources (1)
- FDA UDI 4da1d356-c993-40d9-b071-2ab964c0e6c2 32 fields · synced May 31, 2026