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ACRO BIOTECH Inc.

United States·US-MF-000017832

Last updated September 17, 2026

Information

Country: United States
Address: 4650 Arrow Highway, Suite D-6 , Montclair, United States
Website: acrobiotech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Manuel Grano
EUDAMED SRN: US-MF-000017832
FDA FEI Number: 3005670738
DUNS Number: —

Catalogue (27)

Device	Model / Reference	Registries	Class	Status
PPX Rapid Test Cassette (Whole Blood/Serum/Plasma)	DPP-R402	EUDAMED	IVD General	Active
Fluorescence Immunoassay Analyzer	AFR-ACO300S	EUDAMED	Class A	Active
CAF Rapid Test Cassette (Urine)	acrCAF102R	EUDAMED	IVD General	Active
Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette	1	FDA UDI	Class II	Active
hCG Enhanced Sensitivity Rapid Test Midstream 10 mIU/mL	1	FDA UDI	Class II	Active
MET Rapid Test Cassette	1	FDA UDI	Class II	Active
COC Rapid Test Cassette	1	FDA UDI	Class II	Active
BZO Rapid Test Cassette	1	FDA UDI	Class II	Active
PCP Rapid Test Cassette	1	FDA UDI	U	Active
hCG Enhanced Sensitivity Rapid Test Cassette 10 mIU/mL	1	FDA UDI	Class II	Active
AMP Rapid Test Cassette	1	FDA UDI	Class II	Active
OPI Rapid Test Cassette	1	FDA UDI	Class II	Active
hCG Rapid Test Midstream 25 mIU/mL	1	FDA UDI	Class II	Active
MDMA Rapid Test Cassette	1	FDA UDI	Class II	Active
hCG Rapid Test Cassette 25 mIU/mL	1	FDA UDI	Class II	Active
FOB Rapid Test Cassette	1	FDA UDI	Class II	Active
THC Rapid Test Cassette	1	FDA UDI	Class II	Active
Acro Biotech Llc Rapid Tetrahydrocannabinol Urine Test; Catalog# Opi001000	K053034	FDA 510(k)	Class II	Active
Acro Biotech Llc Rapid Mdma Urine Test, Catalog Mdma0010000	K060355	FDA 510(k)	Class II	Active
Acro Biotech Llc Rapid Amphetamine Urine Test; Catalog# Amp001000	K053032	FDA 510(k)	Class II	Active
Acro Rapid Phencyclidine Urine Test, Catalog Pcp001000	K060353	FDA 510(k)	U	Active
Acro Biotech Llc Rapid Benzoylecgonine Urine Test; Catalog# Met001000	K053035	FDA 510(k)	Class II	Active
Acro HCG Pregnancy Rapid Test	K180771	FDA 510(k)	Class II	Active
ACRO HCG Pregnancy Rapid Test	K172512	FDA 510(k)	Class II	Active
Acro Biotech Llc Rapid Opiates Urine Test; Catalog# Opi00100	K053037	FDA 510(k)	Class II	Active
Acro Biotech Llc Rapid Methamphetamine Urine Test; Catalog# Met001000	K053033	FDA 510(k)	Class II	Active
Acro Biotech Llc Rapid Benzodiazepine Urine Test, Catalog Bzd001000	K060354	FDA 510(k)	Class II	Active

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