← Back to catalogue

T3 SBS AccuLite CLIA Test System - 96 Wells

FDA UDI

Class II (US FDA UDI)

by Monobind, Inc.

Identity

Trade Name
T3 SBS AccuLite CLIA Test System - 96 Wells FDA UDI
Generic Name
Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
8175-300 FDA UDI

Identifiers

Catalog Number
8175-300A FDA UDI
Primary DI / UDI-DI
00816870023014 FDA UDI
FDA Product Code
CDP FDA UDI
GMDN Term
Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1710 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

Yes

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

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 7.75 Inch FDA UDI

Category: Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

T3 SBS AccuLite CLIA Test System - 96 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay.

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
Monobind, Inc.

Sources (1)

  • FDA UDI d172ed7e-ff0f-4823-9d78-d27f3290da78 36 fields · synced May 30, 2026