Identity
- Trade Name
- Decloaking Chamber™ NxGen FDA UDI
- Generic Name
- Pressurized incubator IVD FDA UDI
- Model / Reference
- DC2012-220V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627023513 FDA UDI
- FDA Product Code
- KPA FDA UDI
- GMDN Term
- Pressurized incubator IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3800 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pressurized incubator IVD
Decloaking Chamber™ NxGen by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pressurized incubator IVD.
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- Decloaking Chamber™ NxGen Reconditioned — BIOCARE MEDICAL, LLC · Class I
- ARC – Antigen Retrieval Chamber — BIOCARE MEDICAL, LLC · Class I
- ARC – Antigen Retrieval Chamber — BIOCARE MEDICAL, LLC · Class I
- Decloaking Chamber™ NxGen — BIOCARE MEDICAL, LLC · Class I
- Decloaking Chamber™ NxGen Reconditioned — BIOCARE MEDICAL, LLC · Class I
- ARCHV – Antigen Retrieval Chamber High Voltage (Recertified) — 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 bcd65a61-58d2-44eb-9f0e-3b27236ebefd 32 fields · synced May 30, 2026