Identity
- Trade Name
- Minivette® POCT 100µl K3E FDA UDI
- Generic Name
- Capillary blood collection tube IVD, K2EDTA FDA UDI
- Model / Reference
- 17.2113.102 FDA UDI
Identifiers
- Catalog Number
- 17.2113.102 FDA UDI
- Primary DI / UDI-DI
- 04038917404471 FDA UDI
- FDA Product Code
- GIO FDA UDI
- GMDN Term
- Capillary blood collection tube IVD, K2EDTA FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.6150 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
Yes
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, K2EDTA
Minivette® POCT 100µl K3E by Sarstedt Aktiengesellschaft & Co.KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Capillary blood collection tube IVD, K2EDTA.
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- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sarstedt Aktiengesellschaft & Co.KG
Sources (1)
- FDA UDI 2029af9b-158b-4362-acbe-3ba7d1c7e098 34 fields · synced May 31, 2026