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Epoc Bgem Test Card

FDA UDI

Class II (US FDA UDI)

by Epocal Inc

Identity

Trade Name
EPOC BGEM TEST CARD FDA UDI
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent FDA UDI
Model / Reference
CT-1004-00-00 FDA UDI

Identifiers

Catalog Number
CT-1004-00-00 FDA UDI
Primary DI / UDI-DI
00809708047283 FDA UDI
FDA Product Code
CEM FDA UDI
CGA FDA UDI
CGZ FDA UDI
CHL FDA UDI
JFP FDA UDI
JGS FDA UDI
KHP FDA UDI
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1600 FDA UDI
862.1345 FDA UDI
862.1170 FDA UDI
862.1120 FDA UDI
862.1145 FDA UDI
862.1665 FDA UDI
862.1450 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

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 blood gas/haemoximetry/electrolyte analyte IVD, reagent

Epoc Bgem Test Card by Epocal Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epocal Inc

Sources (1)

  • FDA UDI d5dc330e-6b1b-42b4-a54f-38ea2546a2d8 34 fields · synced May 30, 2026