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ARCHV – Antigen Retrieval Chamber High Voltage (Recertified)

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name
ARCHV – Antigen Retrieval Chamber High Voltage (Recertified) FDA UDI
Generic Name
Pressurized incubator IVD FDA UDI
Model / Reference
DCARC0003-R FDA UDI

Identifiers

Primary DI / UDI-DI
00847627035509 FDA UDI
FDA Product Code
LXG FDA UDI
GMDN Term
Pressurized incubator IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 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

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

ARCHV – Antigen Retrieval Chamber High Voltage (Recertified) by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pressurized incubator IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocare Medical, Llc

Sources (1)

  • FDA UDI 61265a7c-875a-43cc-a492-2b50e978c308 32 fields · synced May 31, 2026