Home›USA›ACRO BIOTECH, INC

ACRO BIOTECH, INC

USA · Montclair

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 7 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

138listed device types

Class I 35Class II 88Class III 5unclassified 10

plus 143 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

91registered devices

Class I 4Class II 87

149 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

20active device licences

Class II 20

110 including historic records

TWTaiwanTFDA

19valid device licences

Class I 18Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 3 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

19registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 1Class 3 1

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 States143 registration records, 10 510(k), 0 PMA, 4 excluded

Brazil91 confirmed, 0 excluded

Canada20 confirmed, 0 excluded

Manufacturer names merged into this page: ACRO BIOTECH Inc. · ACRO BIOTECH INC. · ACRO BIOTECH, INC. (MONTCLAIR) · ACRO BIOTECH INC · ACRO BIOTECH, INC

FDA 510(k) clearances by year

82006 · K060355

22018 · K180771

FDA listed device types

showing 8 of 138

Enzyme Immunoassay, Benzodiazepine 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Biosensor, Immunoassay, Myoglobin 1System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer 1Antigens, All, Leptospira Spp. 1Test, Tricyclic Antidepressants, Over The Counter 1Test, Benzodiazepine, Over The Counter 1Prescription Use Blood Glucose Meter For Near-Patient Testing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180771	Acro HCG Pregnancy Rapid Test	2018-05-18
US	K172512	ACRO HCG Pregnancy Rapid Test	2018-02-02
US	K060355	ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000	2006-08-07
BR	81325990231	Família Cassete de Teste de Vitamina D (Soro/Plasma)	Class II
BR	81325990092	Cassete de Teste Rápido de Entamoeba histolytica (Fezes)	Class II
BR	81325990093	Cassete de Teste Rápido de Giardia lamblia (Fezes)	Class II
CA	102494	ACRO FYL RAPID TEST DIPSTICK (URINE)	Class II
CA	102495	ACRO FYL RAPID TEST CASSETTE (URINE)	Class II
CA	102496	ACRO FYL RAPID TEST PANEL (URINE)	Class II

ACRO BIOTECH, INC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies

ACRO  BIOTECH, INC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies

ACRO BIOTECH, INC