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Glutathione Reductase Calibration Serum (glut Red Cal)

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL) FDA UDI
Generic Name
Glutathione reductase IVD, calibrator FDA UDI
Model / Reference
GR2609 FDA UDI

Identifiers

Primary DI / UDI-DI
05055273203424 FDA UDI
FDA Product Code
JIT FDA UDI
GMDN Term
Glutathione reductase IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 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

No

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

No

FDA UDI

Category: Glutathione reductase IVD, calibrator

Glutathione Reductase Calibration Serum (glut Red Cal) by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI a7cece04-052d-40d4-b2e2-9a135f75f9b6 32 fields · synced Jun 8, 2026