Identity
- Trade Name
- PRESAGE ST2 Controls Kit FDA UDI
- Generic Name
- Multiple cardiac marker IVD, control FDA UDI
- Model / Reference
- BC-1065x FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00867556000171 FDA UDI
- GMDN Term
- Multiple cardiac marker IVD, control FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Multiple cardiac marker IVD, control
PRESAGE ST2 Controls Kit by Critical Care Diagnostics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Liquichek — Bio-Rad Laboratories · Class I
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
- Critical Care Diagnostics, Inc.
Sources (1)
- FDA UDI b9a842d7-ab31-4c85-91ef-e0e3b92674c9 32 fields · synced May 30, 2026