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BTA stat

FDA UDI

Class II (US FDA UDI)

by Polymedco Cancer Diagnostic Products Llc

Identity

Trade Name
BTA stat FDA UDI
Generic Name
Bladder tumour associated antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
BTA stat Test - 5 Test kit - Hitado Labeled FDA UDI
Model / Reference
661505 FDA UDI
Description
BTA stat Test - 5 Test kit - Hitado Labeled FDA UDI

Identifiers

Primary DI / UDI-DI
00855574005278 FDA UDI
510(k) Number
K974845 FDA UDI
FDA Product Code
MMW FDA UDI
GMDN Term
Bladder tumour associated antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.6010 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bladder tumour associated antigen IVD, kit, rapid ICT, clinical

BTA stat by Polymedco Cancer Diagnostic Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bladder tumour associated antigen IVD, kit, rapid ICT, clinical.

Cleared under the same submission

K974845 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Polymedco Cancer Diagnostic Products Llc

Sources (1)

  • FDA UDI 3ac19062-3a21-44e8-ba41-ea4b51413a34 35 fields · synced May 30, 2026