← Back to catalogue

Sall4

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name
SALL4 FDA UDI
Generic Name
Sal-like protein 4 (SALL4) IVD, antibody FDA UDI
Model / Reference
AVI384G FDA UDI

Identifiers

Primary DI / UDI-DI
00847627023872 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Sal-like protein 4 (SALL4) 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: Sal-like protein 4 (SALL4) IVD, antibody

Sall4 by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sal-like protein 4 (SALL4) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biocare Medical, Llc

Sources (1)

  • FDA UDI 7b4f3e2d-d2e8-43fa-b43c-03b9841dec52 33 fields · synced May 30, 2026