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Alfa Wassermann Diagnostics Technologies, LLC

USA · West Caldwell

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

37listed device types

Class I 15Class II 22Class III 0

plus 23 registration records and 35 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States23 registration records, 35 510(k), 0 PMA

Manufacturer names merged into this page: ALFA WASSERMANN

Same-named companies — This database also contains companies with near-identical names: Alfa Wassermann, Inc., Alfa Wassermann Diagnostic Technologies, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12007

82008

52009

12011

122012

72013

12018

FDA listed device types

showing 8 of 37

Alkaline Picrate, Colorimetry, Creatinine 1Calibrator, Primary 1Electrode, Ion-Specific, Chloride 1Biuret (Colorimetric), Total Protein 1Hexokinase, Glucose 1Ferritin, Antigen, Antiserum, Control 1Radioassay, Triiodothyronine Uptake 1Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K170623	ACE Hemoglobin A1c (HbA1c) Reagent	2018-02-27
US	K131975	ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT	2013-10-02
US	K131488	ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT	2013-08-19

Alfa Wassermann Diagnostics Technologies, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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