Identity
- Trade Name
- PTS Diagnostics Capillary Tubes FDA UDI
- Generic Name
- Capillary blood collection tube IVD, no additive FDA UDI
- Device Name
- PTS Collect Capillary Tubes are intended to obtain a drop of whole blood from a fingerstick for self-testing. Capillary tubes are single-use only. Do not reuse. FDA UDI
- Model / Reference
- REF 4774 FDA UDI
- Description
- PTS Collect Capillary Tubes are intended to obtain a drop of whole blood from a fingerstick for self-testing. Capillary tubes are single-use only. Do not reuse. FDA UDI
Identifiers
- Catalog Number
- 4774 FDA UDI
- Primary DI / UDI-DI
- 00381934774015 FDA UDI
- FDA Product Code
- GIO FDA UDI
- GMDN Term
- Capillary blood collection tube IVD, no additive 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Capillary blood collection tube IVD, no additive
PTS Diagnostics Capillary Tubes by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Polymer Technology Systems
Sources (1)
- FDA UDI 753b28d5-2467-48af-848a-2973d4d2ed54 36 fields · synced May 30, 2026