← Back to catalogue

AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 Wells

FDA UDI

Class II (US FDA UDI)

by Monobind, Inc.

Identity

Trade Name
AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 Wells FDA UDI
Generic Name
Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
8525-300 FDA UDI

Identifiers

Catalog Number
8525-300B FDA UDI
Primary DI / UDI-DI
00816870020884 FDA UDI
FDA Product Code
LOJ FDA UDI
GMDN Term
Trisomy 21-risk hormone 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: Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA)

AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA).

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 26e26b55-f486-40ed-8b81-3539697a7f20 36 fields · synced Jun 1, 2026