← Back to catalogue
S-100 (4C4.9) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 330M-10Model 330M-1X seriesRef 330M-17Ref 330M-18Ref 330M-16
Identity
- Trade Name
- S-100 (4C4.9) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- S100 protein IVD, antibody FDA UDI
- Device Name
- S-100 (4C4.9) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 330M-17 EUDAMEDFDA UDI330M-10 EUDAMEDFDA UDI330M-18 EUDAMEDFDA UDI330M-16 EUDAMEDFDA UDI330M-1X series EUDAMED330M-14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683116196 EUDAMEDFDA UDI00841683136484 EUDAMEDFDA UDI00841683116158 EUDAMEDFDA UDI00841683116189 EUDAMEDFDA UDI00841683116202 FDA UDI
- Basic UDI-DI
- 008416831330M-1BH EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- S100 protein IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Prescription Use
No
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: S100 protein IVD, antibody
S-100 (4C4.9) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as S100 protein IVD, antibody.
- Tinto S100A8/MRP8 (RBT-MRP8) — BIO SB, INC. · Class I
- S100P (RBT-S100P) — BIO SB, INC. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Anti-S100P — Biogenex Laboratories, Inc. · Class I
- IHC — Slmp, LLC · Class I
- Tinto S100A6 RMab — BIO SB, INC. · Class I
- S100A9 RMab — BIO SB, INC. · Class I
- S100 Protein [4C4.9] (M) — BIOCARE MEDICAL, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (9)
- FDA UDI 6218b8f3-0b37-4b0a-85df-5487228bf63c 33 fields · synced Jul 25, 2026
- FDA UDI bfbf3f5c-30e5-436c-92d5-435601384815 33 fields · synced May 29, 2026
- FDA UDI 67371990-6d46-4b5a-b9b4-848ae0b28f1c 33 fields · synced May 29, 2026
- FDA UDI 8a65509b-8367-4ecd-b38d-52e81f9292fd 33 fields · synced May 30, 2026
- FDA UDI 46b695eb-a780-4fea-8566-d7e2c51e1e3c 33 fields · synced May 30, 2026
- EUDAMED 57fb9f5a-edf0-45b7-b0fb-1762ffd67b46 61 fields · synced Jul 9, 2026
- EUDAMED 0f648909-29cf-49fb-baf1-cd388bd3be4d 61 fields · synced Jul 19, 2026
- EUDAMED ba3ddcab-6b09-4926-9de1-953b71c59c99 61 fields · synced Jul 20, 2026
- EUDAMED a8971c94-86cb-452a-bac8-e367815146bb 61 fields · synced Jul 25, 2026