← Back to catalogue

Tumor Associated Glycoprotein [B72.3]

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name
Tumor Associated Glycoprotein [B72.3] FDA UDI
Generic Name
Tumour-associated glycoprotein-72 (TAG72) IVD, antibody FDA UDI
Model / Reference
NPAI002T40 FDA UDI

Identifiers

Primary DI / UDI-DI
00847627041715 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Tumour-associated glycoprotein-72 (TAG72) 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: Tumour-associated glycoprotein-72 (TAG72) IVD, antibody

Tumor Associated Glycoprotein [B72.3] by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tumour-associated glycoprotein-72 (TAG72) 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 b0e3344c-602a-4698-9344-14d87a71f371 33 fields · synced Jun 8, 2026