FDA Registration
Active
🇺🇸 United States
Inactivated Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG) HE0045N
Reg #: 2150138
·
FEI: 2150138
·
Expires 2025
Products
1
Proprietary Names
91
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MICROBIOLOGICS, INC.
- Registration Number
- 2150138
- FEI Number
- 2150138
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 200 Cooper Avenue North
- City
- Saint Cloud
- State
- MN
- ZIP
- 56303
- Country
- US
Owner / Operator
- Firm Name
- MICROBIOLOGICS, INC.
- Operator Number
- 2150138
- Address
- 200 Cooper Avenue North, --
- City
- Saint Cloud
- State
- MN
- Postal Code
- 56303
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2013-11-18 |
Proprietary Names
Inactivated Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG) HE0045N
Helix Elite HE0035N Inactivated Chlamydia trachomatis
Helix Elite Inactivated Neisseria gonorrhoeae HE0041N
8210 Enteric Viral Verification Panel
8178 SA Organism Set (Live Culture)
Helix Elite HE0013S Norovirus GI.1 Synthetic RNA
5248P Gram Positive Identification Panel
8189 Trichomonas vaginalis (TV) Control Panel (Inactivated Swab)
Gram-Negative Blood Culture Control Panel (Inactivated Pellet) 8181
8205 Norovirus Control Panel (Inactivated Swab)
5225P Gram-Positive Blood Culture Control Panel (Live Culture)
8174 MRSA Organism Set (Live Culture)
Helix Elite Inactivated Respiratory Syncytial Virus A HE0028N
Helix Elite Inactivated Trichomonas vaginalis HE0042N
8211 Enteric Viral Control Panel
8209 Vaginal Control Panel
Helix Elite Inactivated Influenza B Virus HE0030N
Helix Elite HE0036N Inactivated Herpes Simplex Virus 1
Helix Elite HE0038N Inactivated Varicella Zoster Virus
Helix Elite HE0040N Inactivated Cytomegalovirus High Control
Helix Elite HE0039N Inactivated Cytomegalovirus Low Control
8228 CT/GC/TV Control Panel (Inactivated Pellet)
8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Helix Elite HE0055NS Methicillin-Susceptible Staphylococcus epidermidis (MSSE) Inactivated Swab
5246P Anaerobe Identification Panel
8191 Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
8206 Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Inactivated Pellet)
8179 Enteric Bacterial Verification Panel (Live Culture)
Inactivated Influenza A/B and Respiratory Syncytial Virus HE0044N
Helix Elite HE0037N Inactivated Herpes Simplex Virus 2
Helix Elite Inactivated Influenza A (H3N2) Virus HE0043N
Helix Elite HE0012S Norovirus GII.4 Synthetic RNA
8190 Enterovirus (EV) Control Panel (Inactivated Swab)
8232 Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
8227 C. difficile Control Panel (Inactivated Swab)
8187 Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel (Inactivated Swab)
Helix Elite Inactivated Influenza A (H1N1) Virus HE0029N
HE0056N Human Papillomavirus 16 (HPV 16) Cellular Control (Inactivated Pellet)
5252P Yeast Identification Panel
8171 C. difficile QC Set (Live Culture)
8208 Vaginal Verification Panel
8173 GBS Verification Panel (Live Culture)
Helix Elite Inactivated Adenovirus 2 HE0026N
Helix Elite HE0031N Inactivated Parainfluenza Virus 1
8219 Group A Streptococcus (GAS) Control Panel
Helix Elite HE0033N Inactivated Parainfluenza Virus 3
5247P Gram Negative Identification Panel
8164 GBS QC Set (Live Culture)
HE0058N Negative Cellularity Control (Inactivated Pellet)
Enteric Pathogens Control Panel (Inactivated Pellet) 8184
8236 Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)
HE0057N Human Papillomavirus 18 (HPV 18) Cellularity Control (Inactivated Pellet)
Gram-Positive Blood Culture Control Panel (Inactivated Pellet) 8180
8231 Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
Helix Elite HE0032N Inactivated Parainfluenza Virus 2
Helix Elite HE0034N Inactivated Chlamydia pneumoniae
Helix Elite HE0052N Inactivated Borrelia burgdorferi
8230 Enteric Parasite Control Panel (Inactivated Pellet)
8238 Rifampicin-Resistant Mycobacterium tuberculosis Negative Control (Inactivated Pellet)
8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)
Helix Elite HE0053NS Methicillin-Resistant Staphylococcus aureus (MRSA) Inactivated Swab
Helix Elite HE0027N Inactivated Rotavirus
8246 Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)
Helix Elite HE0054NS Methicillin-Susceptible Staphylococcus aureus (MSSA) Inactivated Swab
8235 Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)
HE0065N Inactivated SARS-CoV-2 Whole Virus (Pellet)
8234 Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
HE0066NS Inactivated SARS-CoV-2 Whole Virus (Swab)
8247 Respiratory Control Panel (22 Targets)
HE0060S SARS-CoV-2 Synthetic RNA (N Gene Targets)
HE0061S SARS-CoV-2 Synthetic RNA Pool (N/E/RdRp/S Gene Targets)
8243 Cdiff Verification Panel (Live Culture)
8249 Bacterial vaginosis (BV) Control Panel
8254 Blood Culture Identification Control Panel (43 Targets)
HE0067NS Negative Cellularity Control (Inactivated Swab)
8250 Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel
ABT-001 SARS-CoV-2 Verification Panel
HE0059N Inactivated Zika Virus
8245 Multiplex Vaginal Verification Panel
8255 Multiplex Vaginal Control Panel
8242 Rapid Group B Streptococcus (GBS) Control Panel
TVS-01 Tri-Valent Positive Control Swab
TVS-02 Tri-Valent Negative Control Swab
8258 Rapid Group B Streptococcus (GBS) Verification Panel
VV-01 Vaginitis Validation Panel
8268 Rapid SARS-CoV-2 Control Panel
VP-03 Trichomonas Verification Set
HE0081NS Negative Blank Control
CL00016 Flu A/Flu B/SARS-CoV-2 Control Panel Inactivated Swabs
8246-SPL Flu RSV SARS-CoV-2 Control Panel Sample Kit
CL00016 Flu A/Flu B/SARS-CoV-2 Control Panel
Establishment Types
Manufacture Medical Device