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Histamine ELISA

FDA UDI

Class I (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
Histamine ELISA FDA UDI
Generic Name
Multiple biogenic amine neurotransmitter IVD, reagent FDA UDI
Device Name
The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay FDA UDI
Model / Reference
EIA-5827 FDA UDI
Description
The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay FDA UDI

Identifiers

Catalog Number
EIA-5827 FDA UDI
Primary DI / UDI-DI
00840239058270 FDA UDI
FDA Product Code
IAF FDA UDI
GMDN Term
Multiple biogenic amine neurotransmitter IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Category: Multiple biogenic amine neurotransmitter IVD, reagent

Histamine ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple biogenic amine neurotransmitter IVD, reagent.

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 e5ae7fba-0df7-4040-8717-78e6b990fe54 36 fields · synced Jun 1, 2026