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Total PSA AccuBind ELISA Test System - 192 Wells

FDA UDI

Class II (US FDA UDI)

by Monobind, Inc.

Identity

Trade Name
Total PSA AccuBind ELISA Test System - 192 Wells FDA UDI
Generic Name
Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
2125-300 FDA UDI

Identifiers

Catalog Number
2125-300B FDA UDI
Primary DI / UDI-DI
00816870020624 FDA UDI
FDA Product Code
LTJ FDA UDI
GMDN Term
Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA) 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

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 prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)

Total PSA AccuBind ELISA Test System - 192 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Monobind, Inc.

Sources (1)

  • FDA UDI 84b44297-0d1e-49ee-a351-4812522e30bf 36 fields · synced May 29, 2026