Identity
- Trade Name
- RAMP® Myoglobin TEST KIT; 25 TESTS FDA UDI
- Generic Name
- Myoglobin IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- C1103 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10627966005022 FDA UDI
- GMDN Term
- Myoglobin IVD, kit, rapid ICT, clinical FDA UDI
- Models / Variants
- RAMP® Myoglobin 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: Myoglobin IVD, kit, rapid ICT, clinical
RAMP® Myoglobin TEST KIT - 25 TESTS by Response Biomedical Corp — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as Myoglobin IVD, kit, rapid ICT, clinical.
- LifeSign® MI StatusFirst CK-MB/Myo/TnI card — PRINCETON BIOMEDITECH CORP. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- LifeSign® MI Myo/TnI card — PRINCETON BIOMEDITECH CORP. · Class II
- LifeSign® MI StatusFirst CK-MB/Myo/TnI card — PRINCETON BIOMEDITECH CORP. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- LifeSign® MI CK-MB/Myo/TnI card — PRINCETON BIOMEDITECH CORP. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Response Biomedical Corp
Sources (1)
- FDA UDI 552e459d-1588-42e0-98a1-169fbf0ab739 32 fields · synced May 30, 2026