Identity
- Trade Name
- DCA 2000® Microalbumin Creatinine control kit FDA UDI
- Generic Name
- Microalbumin IVD, control FDA UDI
- Device Name
- The DCA Microalbumin Creatinine Control Kit contains both Low Controls and High Controls. Each control is a buffered aqueous solution containing known amounts of human albumin and creatinine. The resulting mixture is then lyophilized to ensure stability. The DCA Microalbumin Creatinine Control Kit has been designed for use with the DCA Microalbumin Creatinine Reagent Kit. FDA UDI
- Model / Reference
- 10325406 FDA UDI
- Description
- The DCA Microalbumin Creatinine Control Kit contains both Low Controls and High Controls. Each control is a buffered aqueous solution containing known amounts of human albumin and creatinine. The resulting mixture is then lyophilized to ensure stability. The DCA Microalbumin Creatinine Control Kit has been designed for use with the DCA Microalbumin Creatinine Reagent Kit. FDA UDI
Identifiers
- Catalog Number
- 6012A FDA UDI
- Primary DI / UDI-DI
- 00630414535722 FDA UDI
- 510(k) Number
- K963142 FDA UDI
- FDA Product Code
- JIR FDA UDI
- GMDN Term
- Microalbumin IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1645 FDA UDI
- 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Microalbumin IVD, control
DCA 2000® Microalbumin Creatinine control kit by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 5330fbcd-b401-4ce0-8c4c-327cb2a822f4 37 fields · synced Jun 8, 2026