Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005360469

FEI Number

3005670738

Entity Name

ACRO BIOTECH Inc.

City/State/Country

Montclair, CA, US

Establishment Address

4650 Arrow Hwy Suite D6, Montclair, CA 91763, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Acro Biotech Inc. (Owner Number: 10043465)

Owner / Operator Contact Address

4650 Arrow Hwy Suite D6, Montclair, CA 91763, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Phencyclidine (PCP) Rapid Test Cassette Oral Fluid Phencyclidine (PCP) PCP Rapid Test Panel Powder ACRO Fentanyl Urine Test Cassette Zika NS1 Rapid Test Cassette Zika IgG/IgM Rapid Test Cassette Zika IgG/IgM and NS1 Combo Rapid Test Cassette Influenza A+B Rapid Test Cassette Dengue Rapid Test Cassette Dengue Combo Rapid Test Cassette Instest Urine Analyzer Optilyte Urine Analyzer Beacan Urine Analyzer BZD 300 Rapid Urine Test Acro Biotech Inc. BZD Rapid Urine Test BZD 200 Rapid Urine Test Norovirus Rapid Test Cassette Hb+Hb/Hp Combo Rapid Test Cassette CK-MB Rapid Test Cassette Malaria P.f./P.v. Rapid Test Cassette Malaria P.f. Rapid Test Dipstick Malaria P.f. Rapid Test Cassette Malaria P.f./ Pan Rapid Test Cassette H-FABP Rapid Test Cassette Acro Biotech Inc. Strep A Dipstick Strep A Rapid Test Dipstick Pregabalin (PGB) Rapid Test Cassette Gabapentin(GAB) Rapid Test Dipstick Pregabalin (PGB) Rapid Test Panel Gabapentin(GAB) Rapid Test Cassette Gabapentin(GAB) Rapid Test Panel Pregabalin (PGB) Rapid Test Dipstick Propoxyphene (PPX) Rapid Test Dipstick Propoxyphene (PPX) Rapid Test Cassette Propoxyphene (PPX) Rapid Test Panel Cryptosporidium Rapid Test Cassette NT-proBNP Rapid Test Cassette Carisoprodol(CAR) Rapid Test Panel Carisoprodol(CAR) Rapid Test Dipstick Carisoprodol(CAR) Rapid Test Cassette Acro Biotech Inc. Troponin I Rapid Test Troponin I Rapid Test Chlamydia Rapid Test Cassette AFP Rapid Test Cassette CMV IgG Rapid test Cassette CMV IgM Rapid test Cassette CMV IgG/IgM Combo Rapid test Cassette Cotinine (COT) Rapid Test Panel Powder Cotinine (COT) Rapid Test Cassette Oral Fluid Fentanyl Test (Urine) C-reactive protein Rapid Test Cassette C-reactive protein Semi-Quantitative Rapid Test Cassette C-reactive protein Rapid Test Dipstick C-reactive protein Semi-Quantitative Rapid Test Dipstick C-reactive protein Semi-Quantitative Rapid Test Cassette Methaqualone (MQL) Rapid Test Dipstick Methaqualone (MQL) Rapid Test Panel Methaqualone (MQL) Rapid Test Cassette Acro Biotech Inc. COC Rapid Urine Test COC 300 Rapid Urine Test Lactoferrin Rapid Test Cassette PSA Rapid Test Cassette PSA Qualitative Rapid Test Cassette Insulin-like Growth Factor-binding Protein 1 (iGFBP-1) Rapid Test Cassette MDMA 300 Rapid Urine Test Acro Biotech Inc. MDMA Rapid Urine Test CK-MB Rapid Test Cassette Tuberculosis (TB) Rapid Test Dipstick Tuberculosis (TB) Rapid Test Cassette Legionella Rapid Test Cassette Pregnancy (hCG) Enhanced Sensitivity Rapid Test Cassette - 10 mIU/mL Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream - 10 mIU/mL Salmonella Typhi Antigen Rapid Test Cassette Typhoid Rapid Test Cassette Tricyclic Antidepressants (TCA) Rapid Test Cassette Tricyclic Antidepressants (TCA) Rapid Test Dipstick Tricyclic Antidepressants (TCA) Rapid Test Panel Tricyclic Antidepressants (TCA) Rapid Test Panel Powder ACRO Multi-Drug Rapid Urine Test Cup (prescription & CLIA WAIVED) ACRO hCG Pregnancy Combo Test HCG Pregnancy Urine/Serum Rapid Test Cassette Acro Biotech Inc. HCG Pregnancy Urine/Serum Rapid Combo Test Cassette MONO Rapid Test Cassette PCP 25 Rapid Urine Test Acro Biotech Inc. PCP Rapid Urine Test Acetaminophen (ACE) Rapid Test Panel Powder HBV Combo Rapid Test Cassette HBsAg Rapid Test Dipstick HBsAg and HCV Combo Rapid Test Cassette HBsAg Rapid Test Cassette HBeAg Rapid Test Cassette EBNA IgG Rapid Test Cassette EBV VCA and EBNA IgG Combo Rapid Test Cassette EBV VCA IgG Rapid Test Cassette Influenza A Rapid Test Cassette Candida albicans Rapid Test Alcohol Saliva Rapid Test Acro Biotech Inc. Alcohol Saliva Rapid Test ACRO Multi-Drug Rapid Test Panel; ACRO Multi-Drug Rapid Urine Test Panel Acro Biotech Inc. HCG OTC Rapid Urine Test Midstream HCG Pregnancy Rapid Test Midstream AMP 1000 Rapid Urine Test Acro Biotech Inc. AMP Rapid Urine Test AMP 300 Rapid Urine Test Zolpidem(ZOL) Rapid Test Dipstick Zolpidem(ZOL) Rapid Test Cassette Zopiclone(ZOP) Rapid Test Cassette Zopiclone(ZOP) Rapid Test Panel Zolpidem(ZOL) Rapid Test Panel Powder Benzodiazepines (BZO) Rapid Test Cassette Oral Fluid Alprazolam(ALP) Rapid Test Cassette Alprazolam(ALP) Rapid Test Panel Diazepam (DIA) Rapid Test Panel Powder Benzodiazepines (BZO) Rapid Test Panel Powder Zolpidem(ZOL) Rapid Test Panel Alprazolam(ALP) Rapid Test Dipstick Zopiclone(ZOP) Rapid Test Dipstick Dengue NS1 Rapid Test Cassette- For Export Only Myoglobin Rapid Test Cassette Buprenorphine (BUP) Rapid Test Panel Urine Carfentanyl (CFYL) Rapid Tests Panel Urine Carfentanyl(CFYL) Rapid Test Cassette Oral Fluid 6-Monoacetylmorphine (6-MAM) Rapid Test Midstream Oral Fluid Carfentanyl(CFYL) Rapid Test Midstream Oral Fluid Oxycodone (OXY) Rapid Test Panel Powder Buprenorphine (BUP) Rapid Test Cassette Urine 6-Monoacetylmorphine (6-MAM)Rapid Test Panel Powder Buprenorphine (BUP) Rapid Test Panel Powder BUP Rapid Test Cassette WB Fentanyl (FYL) Rapid Test Panel Urine TML Rapid Test Cassette WB Carfentanyl (CFYL) Rapid Tests Dipstick Urine Carfentanyl(CFYL) Rapid Test Panel Powder 6-Monoacetylmorphine (6-MAM)Rapid Test Panel Urine 6-Monoacetylmorphine(6-MAM) Rapid Test Dipstick Urine Tropicmide(TRO)Rapid Test Panel Urine Fentanyl (FYL) Rapid Test Panel Powder Fentanyl (FYL) Rapid Test Dipstick Urine Tramadol (TML) Rapid Test Dipstick Urine Fentanyl (FYL) Rapid Test Cassette Urine Carfentanyl (CFYL) Rapid Tests Cassette Urine 6-Monoacetylmorphine (6-MAM) Rapid Test Cassette Urine Tramadol (TML) Rapid Test Panel Powder Tropicmide(TRO) Rapid Test Dipstick Urine Carfentanyl (CFYL) Rapid Test Dipstick Urine 6-Monoacetylmorphine (6-MAM) Rapid Test Cassette Oral Fluid OXY Rapid Test Cassette WB Carfentanyl (CFYL) Rapid Test Panel Urine Buprenorphine (BUP) Rapid Test Dipstick Urine Carfentanyl (CFYL) Rapid Test Cassette Urine Tramadol (TML) Rapid Test Panel Urine Tramadol (TML) Rapid Test Cassette Urine Tropicmide(TRO)Rapid Test Cassette Urine Ferritin Rapid test cassette Ferritin Semi-Quantitative Rapid test casssette Brucella Aborts Antigen and Melitensis IgG/IgM Rapid Test Cassette Brucella Melitensis IgG/IgM Rapid Test Cassette Acro Biotech Inc. MET Rapid Urine Test MET 500 Rapid Urine Test MET 300 Rapid Urine Test ACRO Multi-Drug Urine Test Cup ACRO Multi-Drug Test Panel ACRO Multi-Drug Urine Test Panel ACRO Multi-Drug Test Cup Leptospira IgG/IgM Rapid Test Cassette Methadone (MTD) Rapid Test Dipstick Methadone (MTD) Rapid Test Panel Powder Methadone (MTD) Rapid Test Cassette Oral Fluid Methadone (MTD) Rapid Test Cassette Methadone (MTD) Rapid Test Panel Astrovirus Rapid Test Cassette Adenovirus Rapid Test Cassette Lysergic Acid Diethylamide (LSD) Rapid Test Cassette Lysergic Acid Diethylamide (LSD) Rapid Test Panel Lysergic Acid Diethylamide (LSD) Rapid Test Panel Powder Lysergic Acid Diethylamide (LSD) Rapid Test Dipstick HCG Pregnancy Rapid Test Dipstick Acro Biotech Inc. HCG Rx Rapid Urine Test Dipstick FSH Rapid Test Dipstick FSH Rapid Test Midstream FSH Rapid Test Cassette HIV 1.2 Rapid Test Dipstick HIV 1.2 Rapid Test Cassette HIV 1.2.O Rapid Test Cassette TSH Rapid Test Cassette Gonorrhea Rapid Test Cassette D-dimer Rapid Test Cassette Ovulation (LH) Enhanced Sensitivity Rapid Test Dipstick Ovulation (LH) Enhanced Sensitivity Rapid Test Midstream Ovulation (LH) Rapid Test Cassette Ovulation (LH) Rapid Test Midstream Ovulation (LH) Enhanced Sensitivity Rapid Test Cassette Ovulation (LH) Rapid Test Dipstick HSV 1/2 IgG/IgM Combo Rapid Test Cassette HSV 1/2 IgG Rapid Test Cassette HSV 1/2 IgM Rapid Test Cassette Acro Biotech Inc. HCG O.T.C. Rapid Urine Test Cassette HCG Pregnancy Rapid Test Cassette Hb+Hb-Hp Combo Rapid Test Cassette ACRO Multi-Drug Screen Cup; ACRO Multi-Drug Screen Cup for Home use Human Semen Rapid Test Cassette Human Semen Rapid Test Dipstick Acro Biotech Inc. HCG OTC Rapid Urine Test Midstream HCG Pregnancy Rapid Test Midstream Vitamin D Rapid Test Cassette Fetal Fibronectin (fFN) Rapid Test Cassette IgE Rapid Test Cassette Morphine (MOP) Rapid Test Cassette Morphine (MOP) Rapid Test Panel Morphine (MOP) Rapid Test Dipstick Procalcitonin(PCT) Rapid Test Cassette HAV IgM Rapid Test Cassette CA15-3 Rapid Test Cassette CA19-9 Rapid Test Cassette Giardia Lamblia Rapid Test Cassette Methamphetamine (MET) Rapid Test Cassette Oral Fluid Ecstasy (MDMA) Rapid Test Panel Powder Ecstasy (MDMA) Rapid Test Cassette Oral Fluid Methamphetamine (MET) Rapid Test Panel Powder ACRO Early Pregnancy Rapid Test Rubella IgG Rapid Test Cassette Rubella IgG/IgM Combo Rapid Test Cassette Rubella IgM Rapid Test Cassette Syphilis Rapid Test Dipstick Syphilis Rapid Test Cassette PPX Rapid Test Cassette Propoxyphene (PPX) Rapid Test Cassette Propoxyphene (PPX) Rapid Test Panel Propoxyphene (PPX) Rapid Test Dipstick H. pylori Antibody Rapid Test Cassette Opiates (OPI) Rapid Test Dipstick OPI 2000 Rapid Urine Test Opiates (OPI) Rapid Test Panel OPI 300 Rapid Urine Test Acro Biotech Inc. OPI Rapid Urine Test Opiates (OPI) Rapid Test Cassette Transferrin and FOB Combo Rapid Test Cassette Multi-Drug Rapid Test Cassette Multi-Drug Rapid Test A Cassette Multi-Drug Rapid Test 1-Step Cup Multi-Drug Rapid Test Midstream Multi-Drug Rapid Test Panel Multi-Drug Rapid Test 2-Step Cup Multi-Drug Rapid Test Cup Leishmania IgG/IgM Rapid Test Cassette Mescaline (MES) Rapid Test Dipstick Tenamfetamine (MDA) Rapid Test Dipstick Tenamfetamine (MDA) Rapid Test Cassette AMP Rapid Test Cassette Mescaline (MES) Rapid Test Panel Tenamfetamine (MDA) Rapid Test Panel MDA Rapid Test Cassette Mescaline (MES) Rapid Test Cassette Micro-Albumin Qualitative Rapid Test Dipstick Micro-Albumin Semi-Quantitative Rapid Test Dipstick LF Reader Sperm Concentration Rapid Test Cassette SP-10 Male Fertility Rapid Test Cassette Entamoeba histolytica Rapid Test Cassette Lyme IgG/IgM Rapid Test Ovulation (LH) Enhanced Sensitivity Rapid Test Midstream Ovulation (LH) Rapid Test Cassette Ovulation (LH) Rapid Test Midstream Ovulation (LH) Enhanced Sensitivity Rapid Test Dipstick Ovulation (LH) Rapid Test Dipstick (Canister Pack) Ovulation (LH) Rapid Test Dipstick Ovulation (LH) Enhanced Sensitivity Rapid Test Cassette Ovulation (LH) Enhanced Sensitivity Rapid Test Dipstick (Canister Pack) Clostridium difficilie Toxin Test Cassette Trichomonas Vaginalis Rapid Test Cassette Urinalysis Reagent Dipsticks - 1-11 parameters Vaginal pH Rapid Test Panel RSV Rapid Test Cassette HBsAb Rapid Test Cassette HBcAb Rapid Test Cassette HBeAb Rapid Test Cassette Marijuana (THC) Rapid Test Cassette Oral Fluid Leishmania IgG/IgM Rapid Test Cassette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2016-05-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-03-20
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-03-20
POA	Reagents, Zika Virus Nucleic Acid	Unknown	Class N	N/A	2019-12-11
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2016-05-09
NWY	Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies	Unknown	Class N	N/A	2016-05-09
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2022-09-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2013-02-19
OUC	Norovirus Serological Reagent	Microbiology	Class 2	866.3395	2016-05-09
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2016-05-16
NKF	Immunohistochemistry Antibody Assay, C-Kit	Hematology	Class 3	864.1860	2016-05-18
OAX	Plasmodium Spp. Detection Reagents	Microbiology	Class 2	866.3402	2016-05-09
NUK	For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System	Unknown	Class N	N/A	2020-04-03
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2016-11-01
OTF	Gabapentin Assay	Clinical Toxicology	Class 2	862.3350	2020-04-06
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2016-05-10
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2020-04-03
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2017-02-16
QBK	Meprobamate Test System	Clinical Toxicology	Class 2	862.3590	2020-04-06
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2018-01-29
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	Microbiology	Class 1	866.3120	2016-05-09
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	Unknown	Class 3	N/A	2016-05-18
LKQ	Antibody Igm,If, Cytomegalovirus Virus	Microbiology	Class 2	866.3175	2016-05-09
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2016-05-11
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2026-03-26
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2020-04-03
KXS	Radioimmunoassay, Methaqualone	Clinical Toxicology	Class 2	862.3630	2016-05-10
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2013-02-19
DEG	Lactoferrin, Antigen, Antiserum, Control	Immunology	Class 1	866.5570	2020-04-03
OWM	Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers	Immunology	Class 2	866.6040	2016-05-16
OAM	Immunoassay, Insulin-Like Growth Factor Binding Protein-1	Clinical Chemistry	Class 1	862.1550	2016-05-09
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2013-02-19
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2016-07-22
GRT	Antiserum, Fluorescent, Mycobacterium Tuberculosis	Microbiology	Class 1	866.3370	2016-05-10
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2016-05-09
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2017-07-03
GRL	Antigens, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2016-05-10
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2016-05-11
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-12-12
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-12-12
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-12-12
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-12-12
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-12-12
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-12-12
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-12-12
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-12-12
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-12-12
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-12-12
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2024-03-29
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2017-03-17
GNQ	Antigen, Cf (Including Cf Control), Epstein-Barr Virus	Microbiology	Class 1	866.3235	2016-05-09
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2013-02-19
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2016-05-12
KSJ	System, Identification, Hepatitis B Antigen	Unknown	Class 3	N/A	2016-05-18
MCD	Antigen, Ebv, Capsid	Microbiology	Class 1	866.3235	2020-04-03
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay	Microbiology	Class 2	866.3980	2016-05-09
LHK	Antigen, Id, Candida Albicans	Microbiology	Class 2	866.3165	2020-04-03
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2013-03-21
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-03-26
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-03-26
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-03-26
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-03-26
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-03-26
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-03-26
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-03-26
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-03-26
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-03-26
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-03-26
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2018-06-11
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2013-02-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2016-05-11
OZB	Dengue Nucleic Acid Amplification Assay (Naat)	Microbiology	Class 2	866.3946	2016-05-09
MVE	Biosensor, Immunoassay, Myoglobin	Immunology	Class 2	866.5680	2016-05-16
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2016-05-11
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2020-04-03
GSO	Antigens (Febrile), Agglutination, Brucella Spp.	Microbiology	Class 2	866.3085	2017-02-16
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2013-02-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2025-04-10
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2025-04-10
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2025-04-10
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2025-04-10
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	Class 2	862.3640	2025-04-10
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2025-04-10
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-04-10
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2025-04-10
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2025-04-10
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-04-10
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-04-10
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-04-10
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-04-10
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-04-10
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2025-04-10
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-04-10
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2025-04-10
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2025-04-10
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-04-10
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2025-04-10
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2025-04-10
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2025-04-10
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-04-10
GRY	Antigens, All, Leptospira Spp.	Microbiology	Class 2	866.3350	2016-05-09
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2016-05-10
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2020-04-06
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2016-05-09
DLB	Radioimmunoassay, Lsd (125-I)	Clinical Toxicology	Class 2	862.3580	2016-05-11
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2013-03-12
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2020-04-03
MVX	Antibody, Monoclonal Blocking, Hiv-1	Unknown	Class N	N/A	2016-05-09
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2020-04-03
LGA	Device, Oxidase Test For Gonorrhea	Microbiology	Class 3	866.2420	2016-05-18
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2016-05-16
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2020-04-03
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	Microbiology	Class 2	866.3309	2016-05-09
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2013-03-12
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	2020-04-03
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-03-26
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-03-26
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-03-26
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-03-26
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2026-03-26
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-03-26
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-03-26
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-03-26
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-03-26
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-03-26
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-03-26
MNA	N/A	N/A	Class N/A	N/A	2016-05-16
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2013-03-12
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2020-04-03
LKV	Enzyme Immunoassay, Fetal Fibronectin	Unknown	Class 3	N/A	2016-05-18
CFQ	Radioimmunoassay, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2020-04-03
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	Class 2	862.3640	2016-05-10
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2016-05-16
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2016-05-09
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2020-04-03
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2020-04-03
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-05-12
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2026-03-26
LSD	Rubella, Other Assays	Microbiology	Class 2	866.3510	2016-05-09
JWL	Antigen, Treponema Pallidum For Fta-Abs Test	Microbiology	Class 2	866.3830	2016-05-10
DPN	Thin Layer Chromatography, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2020-04-03
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2016-05-09
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2013-02-19
JNM	Immunochemical, Transferrin	Immunology	Class 2	866.5880	2016-05-16
MVO	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter	Unknown	Class U	N/A	2016-05-18
PIT	Leishmania Spp. Antigen Detection Assay	Microbiology	Class 1	866.3870	2020-04-06
DNI	Liquid Chromatography, Amphetamine	Clinical Toxicology	Class 2	862.3100	2020-04-03
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2016-05-16
QGN	Lateral Flow Immunochromatography Assay For Host Infection Biomarkers	Microbiology	Class 2	866.3230	2020-04-06
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2020-04-06
KHW	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.	Microbiology	Class 2	866.3220	2020-04-03
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2020-04-03
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2013-03-12
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2017-02-16
MJK	Dna Probe, Trichomonas Vaginalis	Microbiology	Class 1	866.2660	2020-04-03
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2016-04-04
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2016-05-09
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2016-05-18
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2016-05-12
OUZ	Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids	Microbiology	Class 1	866.3870	2016-05-09

Official Correspondent

Joseph Fan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Acro Biotech Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K924751	Solarcare Technologies Corp,Inc.	SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY	1992-12-11
K142044	Guangzhou Wondfo Biotech Co., Ltd.	CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE	2014-08-25
K163220	Siemens Healthcare Diagnostics, Inc.	Atellica CH Phencyclidine (Pcp)	2017-04-06
K153050	Co-Innovation Biotech Co., Ltd.	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	2016-04-26
K151478	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo CR3 Keyless Split Sample Cup	2015-07-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2022	Beckman Coulter Inc.	2	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Z-0052-2021	Siemens Healthcare Diagnostics, Inc.	2	Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005360469. Last updated year: 2026. Please use registration number 3005360469 when referencing this establishment in official correspondence.