Establishments and listings

Qamp mini Thermal cycler

BIOPTIC INC. · New Taipei, TW

Manufacture Medical DeviceReg. 3010030414OUL
Proprietary name
Qamp mini Thermal cycler
Establishment type
Manufacture Medical Device
Registration
Registration number
3010030414
FEI number
3010030414
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOPTIC INC.
Address line 1
4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
City
New Taipei
Iso country code
TW
Postal code
23141
US agent
Name
Varoujan Amirkhanian
Bus phone area code
818
Bus phone num
6794413
Email address
varoujamirkhanian@gmail.com
Address line 1
3831 El Caminito,
City
La Crescenta
State code
CA
Iso country code
US
Zip code
91214
Owner operator
Firm name
BiOptic Inc.
Owner operator number
10086887
Official correspondent
First name
Yutien
Last name
Huang
Phone number
886-221-88726-335
Contact address
Address 1
4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
City
New Taipei
State code
TW-NWT
Iso country code
TW
Postal code
23141
Products
  1. Product code
    OUL
    Created date
    2023-02-16
    Owner operator number
    10086887
    Harmonized identifiers (openFDA)
    Device name
    Thermocycler, Generic
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.2310
    Device class
    1
Establishments and listings

LV Module (30/100 sets); 1mm Beads Tube (36/50/250 pcs); 3mm Beads Tube (36/50/250 pcs), Elution Tube (36/50 pcs); EtOH Tube (36/50 pcs); Sample Tube (36/50 pcs); Syringe (36/50 pcs); Tip Set (36/50 pcs) +1

BIOPTIC INC. · New Taipei, TW

Manufacture Medical DeviceReg. 3010030414LXG
Proprietary name
LV Module (30/100 sets); 1mm Beads Tube (36/50/250 pcs); 3mm Beads Tube (36/50/250 pcs), Elution Tube (36/50 pcs); EtOH Tube (36/50 pcs); Sample Tube (36/50 pcs); Syringe (36/50 pcs); Tip Set (36/50 pcs), Micro Vial; Sample tray; Buffer tray; Droppers; PCR tubes; 16+3-well Sample Tube; Rotor plate (for 16+3 tube)
Establishment type
Manufacture Medical Device
Registration
Registration number
3010030414
FEI number
3010030414
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOPTIC INC.
Address line 1
4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
City
New Taipei
Iso country code
TW
Postal code
23141
US agent
Name
Varoujan Amirkhanian
Bus phone area code
818
Bus phone num
6794413
Email address
varoujamirkhanian@gmail.com
Address line 1
3831 El Caminito,
City
La Crescenta
State code
CA
Iso country code
US
Zip code
91214
Owner operator
Firm name
BiOptic Inc.
Owner operator number
10086887
Official correspondent
First name
Yutien
Last name
Huang
Phone number
886-221-88726-335
Contact address
Address 1
4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
City
New Taipei
State code
TW-NWT
Iso country code
TW
Postal code
23141
Products
  1. Product code
    LXG
    Created date
    2023-02-16
    Owner operator number
    10086887
    Harmonized identifiers (openFDA)
    Device name
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.2050
    Device class
    1
Establishments and listings

Proteinase K (1/11/50/100/130 mg); Carrier RNA (12/140/200 ug); Buffer DWX (50/100/200 mL)

BIOPTIC INC. · New Taipei, TW

Manufacture Medical DeviceReg. 3010030414PPM
Proprietary name
Proteinase K (1/11/50/100/130 mg); Carrier RNA (12/140/200 ug); Buffer DWX (50/100/200 mL)
Establishment type
Manufacture Medical Device
Registration
Registration number
3010030414
FEI number
3010030414
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOPTIC INC.
Address line 1
4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
City
New Taipei
Iso country code
TW
Postal code
23141
US agent
Name
Varoujan Amirkhanian
Bus phone area code
818
Bus phone num
6794413
Email address
varoujamirkhanian@gmail.com
Address line 1
3831 El Caminito,
City
La Crescenta
State code
CA
Iso country code
US
Zip code
91214
Owner operator
Firm name
BiOptic Inc.
Owner operator number
10086887
Official correspondent
First name
Yutien
Last name
Huang
Phone number
886-221-88726-335
Contact address
Address 1
4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
City
New Taipei
State code
TW-NWT
Iso country code
TW
Postal code
23141
Products
  1. Product code
    PPM
    Created date
    2023-09-11
    Owner operator number
    10086887
    Harmonized identifiers (openFDA)
    Device name
    General Purpose Reagent
    Medical specialty description
    Pathology
    Regulation number
    864.4010
    Device class
    1
Establishments and listings

Qsep Series Bio-Fragment Analyzer (Qsep1, Qsep1-Lite, Qsep1-Plus; Qsep100, Qsep100 Advance; Qsep400; Qsep400 SE; Qsep400 Advance; QsepUltra);, DNA Cartridges (S1, S2, S3, F3, N1, N3, L1, L2, L3); RNA Cartridges (R1, NR1, LR1); Protein Cartridges (P2); +2

BIOPTIC INC. · New Taipei, TW

Manufacture Medical DeviceReg. 3010030414JJN
Proprietary name
Qsep Series Bio-Fragment Analyzer (Qsep1, Qsep1-Lite, Qsep1-Plus; Qsep100, Qsep100 Advance; Qsep400; Qsep400 SE; Qsep400 Advance; QsepUltra);, DNA Cartridges (S1, S2, S3, F3, N1, N3, L1, L2, L3); RNA Cartridges (R1, NR1, LR1); Protein Cartridges (P2);, Power Supply; Air Pump; Purge Station, Quantitative Cartridge Kit; Quantitative marker; Alignment Marker; Size Marker; Separation Buffer; Dilution Buffer; Mineral Oil;
Establishment type
Manufacture Medical Device
Registration
Registration number
3010030414
FEI number
3010030414
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOPTIC INC.
Address line 1
4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
City
New Taipei
Iso country code
TW
Postal code
23141
US agent
Name
Varoujan Amirkhanian
Bus phone area code
818
Bus phone num
6794413
Email address
varoujamirkhanian@gmail.com
Address line 1
3831 El Caminito,
City
La Crescenta
State code
CA
Iso country code
US
Zip code
91214
Owner operator
Firm name
BiOptic Inc.
Owner operator number
10086887
Official correspondent
First name
Yutien
Last name
Huang
Phone number
886-221-88726-335
Contact address
Address 1
4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
City
New Taipei
State code
TW-NWT
Iso country code
TW
Postal code
23141
Products
  1. Product code
    JJN
    Created date
    2022-12-20
    Owner operator number
    10086887
    Harmonized identifiers (openFDA)
    Device name
    Apparatus, Electrophoresis, For Clinical Use
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.2485
    Device class
    1
Establishments and listings

iCATCHER 12 Dx Automated Nucleic Acid Purification System, CatchGene Dx Catch-cfDNA Serum/Plasma Kit(1000/4000/M4000); CatchGene Dx Catch-cfDNA Urine Kit +13

BIOPTIC INC. · New Taipei, TW

Manufacture Medical DeviceReg. 3010030414JJH
Proprietary name
iCATCHER 12 Dx Automated Nucleic Acid Purification System, CatchGene Dx Catch-cfDNA Serum/Plasma Kit(1000/4000/M4000); CatchGene Dx Catch-cfDNA Urine Kit, iCATCHER Dx DNA Kit(250/1000/4000), iCATCHER Dx Tissue DNA Kit(250/4000), iCATCHER Dx FFPE Tissue DNA Kit, iCATCHER Dx Stool DNA Kit(250/1000/4000), CatchGene Dx RNA Kit (Cell/Tissue/FFPE Tissue/Blood/Ultra Blood/Viral/One Cell), iCATCHER Dx Tissue miRNA Kit, iCATCHER Dx FFPE Tissue miRNA Kit, CatchGene Dx Circulating cfRNA 1000 Kit, iCATCHER Dx Circulating cfDNA/cfRNA Kit(1000/2000/4000), iCATCHER Dx VB DNA/RNA Kit (250/1000), iCATCHER Dx FFPE Tissue DNA/RNA Kit; iCATCHER Dx Circulating cfDNA Kit(1000/2000/4000), CatchGene Dx Circulating cfDNA/cfRNA Kit(1000/4000), iCATCHER Dx Circulating cfRNA Kit(1000/2000/4000), CatchGene Dx miRNA Kit (Cell/Exosome/Tissue/FFPE Tissue); CatchGene Dx Catch-miRNA Serum/Plasma Kit, iCATCHER Dx Circulating cfDNA Kit(1000/2000/4000), CatchGene Dx DNA Kit(Cell/Blood/Saliva/Tissue/FFPE Tissue/Stool/Microbiome/Oil), iCATCHER Dx Blood RNA 1000 Kit, iCATCHER Dx Tissue RNA 1000 Kit, iCATCHER Dx FFPE Tissue RNA Kit, CatchGene Dx DNA/RNA Kit (Viral/Ultra Viral/Exosome/FFPE Tissus)
Establishment type
Manufacture Medical Device
Registration
Registration number
3010030414
FEI number
3010030414
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOPTIC INC.
Address line 1
4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
City
New Taipei
Iso country code
TW
Postal code
23141
US agent
Name
Varoujan Amirkhanian
Bus phone area code
818
Bus phone num
6794413
Email address
varoujamirkhanian@gmail.com
Address line 1
3831 El Caminito,
City
La Crescenta
State code
CA
Iso country code
US
Zip code
91214
Owner operator
Firm name
BiOptic Inc.
Owner operator number
10086887
Official correspondent
First name
Yutien
Last name
Huang
Phone number
886-221-88726-335
Contact address
Address 1
4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
City
New Taipei
State code
TW-NWT
Iso country code
TW
Postal code
23141
Products
  1. Product code
    JJH
    Created date
    2023-09-11
    Owner operator number
    10086887
    Harmonized identifiers (openFDA)
    Device name
    Clinical Sample Concentrator
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.2310
    Device class
    1
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.