Identity
- Trade Name
- TIA-1 EUDAMEDFDA UDI
- Generic Name
- T-cell intracytoplasmic antigen (TIA1) IVD, antibody FDA UDI
- Device Name
- TIA-1 EUDAMED
- Model / Reference
- CM130C EUDAMEDFDA UDIPM130AA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627006363 EUDAMEDFDA UDI00847627011138 FDA UDI
- Basic UDI-DI
- B-00847627006363 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
- GMDN Term
- T-cell intracytoplasmic antigen (TIA1) IVD, antibody FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
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: T-cell intracytoplasmic antigen (TIA1) IVD, antibody
Tia-1 by Biocare Medical, Llc — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as T-cell intracytoplasmic antigen (TIA1) IVD, antibody.
- ANTI-TIA-1 — Biogenex Laboratories, Inc. · Class I
- ANTI-TIA-1 — Biogenex Laboratories, Inc. · Class I
- ANTI-TIA-1 — Biogenex Laboratories, Inc. · Class I
- TIA-1 — BIOCARE MEDICAL, LLC · Class I
- TIA-1 — BIOCARE MEDICAL, LLC · Class I
- TIA-1 — BIOCARE MEDICAL, LLC · Class I
- TIA-1 — BIOCARE MEDICAL, LLC · Class I
- TIA-1 — BIOCARE MEDICAL, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (3)
- FDA UDI b0021928-29b5-468d-b211-d971ffcd1b8b 33 fields · synced Aug 1, 2026
- FDA UDI e00e10c5-5d35-4dfb-af4c-0c91db010670 33 fields · synced May 30, 2026
- EUDAMED 13560070-b2ca-4856-b0f4-accdbf37dd49 61 fields · synced Aug 1, 2026