Phospholin ES w/ Calcium Chloride
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Phospholin ES EUDAMEDPhospholin ES w/ Calcium Chloride FDA UDIPhospholin ES w/Calcium FDA UDI
- Generic Name
- Activated partial thromboplastin time (APTT) IVD, reagent FDA UDI
- Device Name
- Phospholin ES EUDAMEDAPTT reagent 5 x 10 ml with 5 Calcium Chloride FDA UDIAPTT reagent 5 x 5 ml FDA UDI
- Model / Reference
- 21-410 EUDAMEDFDA UDI21-405 EUDAMEDFDA UDI
- Description
- APTT reagent 5 x 10 ml with 5 Calcium Chloride FDA UDIAPTT reagent 5 x 5 ml FDA UDI
Identifiers
- Catalog Number
- 21-410 FDA UDI21-405 FDA UDI
- Primary DI / UDI-DI
- 10859394006016 EUDAMEDFDA UDI10859394006238 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10859394006016 EUDAMEDB-10859394006238 EUDAMED
- 510(k) Number
- K033471 FDA UDI
- FDA Product Code
- GGW FDA UDI
- EMDN Code
- W0103020102 ACTIVATED PARTIAL THROMBOPLASTIN TIME EUDAMED
- GMDN Term
- Activated partial thromboplastin time (APTT) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7925 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Activated partial thromboplastin time (APTT) IVD, reagent
Phospholin ES w/ Calcium Chloride by R2 Diagnostics, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Activated partial thromboplastin time (APTT) IVD, reagent.
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- R2 Diagnostics, Inc.
Sources (4)
- FDA UDI ae9c351f-f3f7-48ca-83e9-9a89bab556bf 35 fields · synced Jul 11, 2026
- FDA UDI bb20d5f1-339b-4e9f-a491-696983b275ab 35 fields · synced May 30, 2026
- EUDAMED 7a8bbe37-8c6a-4549-b90a-6193fea0ff46 61 fields · synced Jul 9, 2026
- EUDAMED 256fa5fe-4e43-4e7a-9093-eec94142bb63 61 fields · synced Jul 11, 2026