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B72.3

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name
B72.3 FDA UDI
Generic Name
Tumour-associated glycoprotein-72 (TAG72) IVD, antibody FDA UDI
Device Name
Alternate name : Tumor Associated Glycoprotein [B72.3] FDA UDI
Model / Reference
PM002AA FDA UDI
Description
Alternate name : Tumor Associated Glycoprotein [B72.3] FDA UDI

Identifiers

Primary DI / UDI-DI
00847627010568 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

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

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Manufacturer

Manufacturer
Biocare Medical, Llc

Sources (1)

  • FDA UDI 7ab5230c-87de-4685-8605-e09fc6b5fe43 34 fields · synced May 29, 2026