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DRG:HYBRiD.XL®

FDA UDI

Class I (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
DRG:HYBRiD.XL® FDA UDI
Generic Name
Enzyme immunoassay (EIA) analyser IVD FDA UDI
Device Name
The DRG:HYBRiD-XL® is a fully automated random access analyzer. The innovative technology of the DRG:HYBRiD-XL® allows users to simultaneously process immunoassays and clinical chemistry parameters, including turbidimetry, on one or more patient samples. The DRG:HYBRiD-XL® can be used for both the quantitative and qualitative (cut-off) evaluation of immunoassays. FDA UDI
Model / Reference
HYB-5252 FDA UDI
Description
The DRG:HYBRiD-XL® is a fully automated random access analyzer. The innovative technology of the DRG:HYBRiD-XL® allows users to simultaneously process immunoassays and clinical chemistry parameters, including turbidimetry, on one or more patient samples. The DRG:HYBRiD-XL® can be used for both the quantitative and qualitative (cut-off) evaluation of immunoassays. FDA UDI

Identifiers

Catalog Number
HYB-5252 FDA UDI
Primary DI / UDI-DI
00840239052520 FDA UDI
FDA Product Code
JJQ FDA UDI
GMDN Term
Enzyme immunoassay (EIA) analyser IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2300 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Enzyme immunoassay (EIA) analyser IVDNephelometry/turbidimetry analyser IVD, automated/semi-automated

DRG:HYBRiD.XL® by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nephelometry/turbidimetry analyser IVD, automated/semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRG International, Inc.

Sources (1)

  • FDA UDI 80732a33-8c11-4aee-beb7-2c96177e2fcd 36 fields · synced May 30, 2026