Identity
- Trade Name
- TIGIT (RM) [BLR047F] FDA UDI
- Generic Name
- TIGIT protein IVD, antibody FDA UDI
- Model / Reference
- API3243AA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627023971 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- TIGIT protein IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: TIGIT protein IVD, antibody
Tigit (rm) [blr047f] by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as TIGIT protein IVD, antibody.
- TIGIT [BC41] — BIOCARE MEDICAL, LLC · Class I
- TIGIT [BC41] — BIOCARE MEDICAL, LLC · Class I
- TIGIT (RM) [BLR047F] — BIOCARE MEDICAL, LLC · Class I
- TIGIT (RM) [BLR047F] — BIOCARE MEDICAL, LLC · Class I
- TIGIT [BC41] — BIOCARE MEDICAL, LLC · Class I
- TIGIT [BC41] — BIOCARE MEDICAL, 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
- Biocare Medical, Llc
Sources (1)
- FDA UDI bf30a38b-802f-4a00-8545-ebd9933719d3 33 fields · synced Jun 8, 2026