Identity
- Trade Name
- DCA® Systems Hemoglobin A1c capillary holders FDA UDI
- Generic Name
- Capillary blood collection tube IVD, electrolyte-balanced heparin FDA UDI
- Device Name
- A blood collection tube holder; to be used with DCA® Systems HbA1c Reagent Cartridge. FDA UDI
- Model / Reference
- 10888741 FDA UDI
- Description
- A blood collection tube holder; to be used with DCA® Systems HbA1c Reagent Cartridge. FDA UDI
Identifiers
- Catalog Number
- 10888741 FDA UDI
- Primary DI / UDI-DI
- 00630414171142 FDA UDI
- 510(k) Number
- K951361 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Capillary blood collection tube IVD, electrolyte-balanced heparin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 FDA UDI
- 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
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: Capillary blood collection tube IVD, electrolyte-balanced heparin
DCA® Systems Hemoglobin A1c capillary holders by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Capillary blood collection tube IVD, electrolyte-balanced heparin.
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Cleared under the same submission
K951361 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2ef1673d-40cf-4698-9cb1-d6655145c17f 37 fields · synced Jun 1, 2026