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Sprinter XL (model 160 samples +2 more)

FDA UDI

Class I (US FDA UDI)

by EUROIMMUN Medizinische Labordiagnostika AG

Identity

Trade Name
Sprinter XL (model 160 samples, IFA/ELISA incl. Incubator) FDA UDI
Generic Name
Enzyme immunoassay (EIA) analyser IVD FDA UDI
Model / Reference
YG 0033-0101-3 FDA UDI

Identifiers

Primary DI / UDI-DI
04049016109686 FDA UDI
FDA Product Code
JJE FDA UDI
GMDN Term
Enzyme immunoassay (EIA) analyser IVD FDA UDI
Models / Variants
model 160 samples FDA UDI
IFA FDA UDI
ELISA incl. Incubator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2160 FDA UDI
Commercial Distribution
Not 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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sprinter XL (model 160 samples +2 more) by EUROIMMUN Medizinische Labordiagnostika AG — Class I — FDA UDI — listed in FDA GUDID — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
EUROIMMUN Medizinische Labordiagnostika AG

Sources (1)

  • FDA UDI 1d9555a3-8344-4c96-8da0-59c7586343f3 33 fields · synced May 30, 2026