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hCG Extended Range AccuLite CLIA Test System - 192 Wells

FDA UDI

Class II (US FDA UDI)

by Monobind, Inc.

Identity

Trade Name
hCG Extended Range AccuLite CLIA Test System - 192 Wells FDA UDI
Generic Name
Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
8875-300 FDA UDI

Identifiers

Catalog Number
8875-300B FDA UDI
Primary DI / UDI-DI
00816870022611 FDA UDI
FDA Product Code
DHA FDA UDI
GMDN Term
Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1155 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: Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay

hCG Extended Range AccuLite CLIA Test System - 192 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Monobind, Inc.

Sources (1)

  • FDA UDI 4e488513-289a-4e78-acab-3e8693e656e6 36 fields · synced Jun 6, 2026