Identity
- Trade Name
- Ki-67 FDA UDI
- Generic Name
- Ki67 antigen IVD, antibody FDA UDI
- Model / Reference
- NPAI325T80 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627037008 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Ki67 antigen 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Ki67 antigen IVD, antibody
Ki-67 by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ki67 antigen IVD, antibody.
- Genemed® — Sakura Finetek USA, Inc · Class I
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- BOND — Leica Biosystems Newcastle, Limited · Class I
- TintoFast Ki-67 RMab — BIO SB, INC. · Class I
- Mono Mo A-Hu Ki-67 Antigen/FITC Cl Ki-67 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- ANTI-KI 67 — Biogenex Laboratories, Inc. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- ANTI-KI67 — Biogenex Laboratories, Inc. · 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 a4a1fda4-d4c4-4630-a017-47b2a3596683 32 fields · synced May 30, 2026