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6-Acetylmorphine Semi-Quantitative Calibrators Set

EUDAMEDFDA UDI

Class B (EU MDR)

Ref 08240183190

by Lin-Zhi International, Inc.

Identity

Trade Name
6-Acetylmorphine Semi-Quantitative Calibrators Set EUDAMEDFDA UDI
Generic Name
6-Acetyl morphine IVD, calibrator FDA UDI
Device Name
6-Acetylmorphine Calibrators and Controls EUDAMED
6-Acetylmorphine Semi-Quantitative Calibrators Set EUDAMED
6AM Negative Calibrator 0 ng/mL (1 x 5 mL), 6AM Low Calibrator 5 ng/mL (1 x 5 mL), 6AM Cutoff Calibrator 10 ng/mL (1 x 5 mL), 6AM Intermediate Calibrator 20 ng/mL (1 x 5 mL), 6AM High Calibrator 40 ng/mL (1 x 5 mL). FDA UDI
Model / Reference
08240183190 EUDAMEDFDA UDI
Description
6AM Negative Calibrator 0 ng/mL (1 x 5 mL), 6AM Low Calibrator 5 ng/mL (1 x 5 mL), 6AM Cutoff Calibrator 10 ng/mL (1 x 5 mL), 6AM Intermediate Calibrator 20 ng/mL (1 x 5 mL), 6AM High Calibrator 40 ng/mL (1 x 5 mL). FDA UDI

Identifiers

Catalog Number
08240183190 FDA UDI
Primary DI / UDI-DI
00850624008056 EUDAMEDFDA UDI
Basic UDI-DI
0850624008CC6AM02PL EUDAMED
B-00850624008056 EUDAMED
Direct Marketing DI
00850624008056 EUDAMED
FDA Product Code
DLJ FDA UDI
EMDN Code
W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
GMDN Term
6-Acetyl morphine IVD, calibrator FDA UDI

Classification

Device Class
Class B EUDAMED
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
862.3200 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

6-Acetylmorphine Semi-Quantitative Calibrators Set by Lin-Zhi International, Inc. — Class B — IVDD, IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lin-Zhi International, Inc.
EUDAMED SRN
US-MF-000003373
Authorised Representative
CEpartner4U NL-AR-000000111

Sources (3)

  • EUDAMED f348fd94-a4cb-4b95-a048-e0c3c31ec0c2 61 fields · synced Oct 7, 2026
  • FDA UDI c86505d5-2a2f-483f-88f4-cd31e73b7cf3 35 fields · synced May 30, 2026
  • EUDAMED 8e7a486e-7591-49fa-b3f5-00d7d32fca11 61 fields · synced Oct 7, 2026