Establishments and listings

BioGenex Mouse Anti-PR (Clone PR88)

BIOGENEX LABORATORIES INC. · Fremont, US

Manufacture Medical DeviceReg. 3008776165MXZ
K number
K012960
Proprietary name
BioGenex Mouse Anti-PR (Clone PR88)
Establishment type
Manufacture Medical Device
Registration
Registration number
3008776165
FEI number
2936532
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOGENEX LABORATORIES INC.
Address line 1
48810 Kato Road,Suite 100E&200E
City
Fremont
State code
CA
Iso country code
US
Zip code
94538
Owner operator
Firm name
BIOGENEX LABORATORIES INC.
Owner operator number
2936532
Official correspondent
First name
KRISHAN
Middle initial
L
Last name
KALRA
Phone number
x-510-8241400-x
Contact address
Address 1
48810 Kato Road,Suite 100E&200E
Address 2
--
City
Fremont
State code
CA
Iso country code
US
Postal code
94538
Products
  1. Product code
    MXZ
    Created date
    2007-12-10
    Owner operator number
    2936532
    Harmonized identifiers (openFDA)
    Device name
    Immunohistochemistry Assay, Antibody, Progesterone Receptor
    Medical specialty description
    Hematology
    Regulation number
    864.1860
    Device class
    2
    K number
    K012960
Establishments and listings

TRYPSIN

BIOGENEX LABORATORIES INC. · Fremont, US

Manufacture Medical DeviceReg. 3008776165IBG
Proprietary name
TRYPSIN
Establishment type
Manufacture Medical Device
Registration
Registration number
3008776165
FEI number
2936532
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOGENEX LABORATORIES INC.
Address line 1
48810 Kato Road,Suite 100E&200E
City
Fremont
State code
CA
Iso country code
US
Zip code
94538
Owner operator
Firm name
BIOGENEX LABORATORIES INC.
Owner operator number
2936532
Official correspondent
First name
KRISHAN
Middle initial
L
Last name
KALRA
Phone number
x-510-8241400-x
Contact address
Address 1
48810 Kato Road,Suite 100E&200E
Address 2
--
City
Fremont
State code
CA
Iso country code
US
Postal code
94538
Products
  1. Product code
    IBG
    Created date
    2005-02-03
    Owner operator number
    2936532
    Harmonized identifiers (openFDA)
    Device name
    Trypsin
    Medical specialty description
    Pathology
    Regulation number
    864.4400
    Device class
    1
Establishments and listings

SUDAN BLACK

BIOGENEX LABORATORIES INC. · Fremont, US

Manufacture Medical DeviceReg. 3008776165HZZ
Proprietary name
SUDAN BLACK
Establishment type
Manufacture Medical Device
Registration
Registration number
3008776165
FEI number
2936532
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOGENEX LABORATORIES INC.
Address line 1
48810 Kato Road,Suite 100E&200E
City
Fremont
State code
CA
Iso country code
US
Zip code
94538
Owner operator
Firm name
BIOGENEX LABORATORIES INC.
Owner operator number
2936532
Official correspondent
First name
KRISHAN
Middle initial
L
Last name
KALRA
Phone number
x-510-8241400-x
Contact address
Address 1
48810 Kato Road,Suite 100E&200E
Address 2
--
City
Fremont
State code
CA
Iso country code
US
Postal code
94538
Products
  1. Product code
    HZZ
    Created date
    2002-03-26
    Owner operator number
    2936532
    Harmonized identifiers (openFDA)
    Device name
    Sudan Black B
    Medical specialty description
    Hematology
    Regulation number
    864.1850
    Device class
    1
Establishments and listings

Safranin O Stain

BIOGENEX LABORATORIES INC. · Fremont, US

Manufacture Medical DeviceReg. 3008776165HZS
Proprietary name
Safranin O Stain
Establishment type
Manufacture Medical Device
Registration
Registration number
3008776165
FEI number
2936532
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOGENEX LABORATORIES INC.
Address line 1
48810 Kato Road,Suite 100E&200E
City
Fremont
State code
CA
Iso country code
US
Zip code
94538
Owner operator
Firm name
BIOGENEX LABORATORIES INC.
Owner operator number
2936532
Official correspondent
First name
KRISHAN
Middle initial
L
Last name
KALRA
Phone number
x-510-8241400-x
Contact address
Address 1
48810 Kato Road,Suite 100E&200E
Address 2
--
City
Fremont
State code
CA
Iso country code
US
Postal code
94538
Products
  1. Product code
    HZS
    Created date
    2013-12-04
    Owner operator number
    2936532
    Harmonized identifiers (openFDA)
    Device name
    Safranin
    Medical specialty description
    Hematology
    Regulation number
    864.1850
    Device class
    1
Establishments and listings

Mucicarmine Stain, Gomori's Blue Trichrome Stain +13

BIOGENEX LABORATORIES INC. · Fremont, US

Manufacture Medical DeviceReg. 3008776165LEE
Proprietary name
Mucicarmine Stain, Gomori's Blue Trichrome Stain, Colloidal Iron, Renal Masson's Trichome, van Gieson Stain, Gomori's Trichrome Green Stain, Reticulin/No Counterstain Stain, PAS for fungi stain, Oil Red O Stain, Jones' Basement Membrane Stain, PAS Diastase, Sudan Black B Stain, Congo Red Stain, ALIZARIN RED STAIN, RETICULIN/NUCLEAR FAST RED STAIN KIT
Establishment type
Manufacture Medical Device
Registration
Registration number
3008776165
FEI number
2936532
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOGENEX LABORATORIES INC.
Address line 1
48810 Kato Road,Suite 100E&200E
City
Fremont
State code
CA
Iso country code
US
Zip code
94538
Owner operator
Firm name
BIOGENEX LABORATORIES INC.
Owner operator number
2936532
Official correspondent
First name
KRISHAN
Middle initial
L
Last name
KALRA
Phone number
x-510-8241400-x
Contact address
Address 1
48810 Kato Road,Suite 100E&200E
Address 2
--
City
Fremont
State code
CA
Iso country code
US
Postal code
94538
Products
  1. Product code
    LEE
    Created date
    2005-02-03
    Owner operator number
    2936532
    Harmonized identifiers (openFDA)
    Device name
    Stains, Dye Solution
    Medical specialty description
    Hematology
    Regulation number
    864.1850
    Device class
    1
Establishments and listings

I6000 AUTOMATED STAINING SYSTEM

BIOGENEX LABORATORIES INC. · Fremont, US

Manufacture Medical DeviceReg. 3008776165KPA
Proprietary name
I6000 AUTOMATED STAINING SYSTEM
Establishment type
Manufacture Medical Device
Registration
Registration number
3008776165
FEI number
2936532
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOGENEX LABORATORIES INC.
Address line 1
48810 Kato Road,Suite 100E&200E
City
Fremont
State code
CA
Iso country code
US
Zip code
94538
Owner operator
Firm name
BIOGENEX LABORATORIES INC.
Owner operator number
2936532
Official correspondent
First name
KRISHAN
Middle initial
L
Last name
KALRA
Phone number
x-510-8241400-x
Contact address
Address 1
48810 Kato Road,Suite 100E&200E
Address 2
--
City
Fremont
State code
CA
Iso country code
US
Postal code
94538
Products
  1. Product code
    KPA
    Created date
    2006-07-18
    Owner operator number
    2936532
    Harmonized identifiers (openFDA)
    Device name
    Slide Stainer, Automated
    Medical specialty description
    Pathology
    Regulation number
    864.3800
    Device class
    1
Establishments and listings

METHYL GREEN

BIOGENEX LABORATORIES INC. · Fremont, US

Manufacture Medical DeviceReg. 3008776165HZA
Proprietary name
METHYL GREEN
Establishment type
Manufacture Medical Device
Registration
Registration number
3008776165
FEI number
2936532
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOGENEX LABORATORIES INC.
Address line 1
48810 Kato Road,Suite 100E&200E
City
Fremont
State code
CA
Iso country code
US
Zip code
94538
Owner operator
Firm name
BIOGENEX LABORATORIES INC.
Owner operator number
2936532
Official correspondent
First name
KRISHAN
Middle initial
L
Last name
KALRA
Phone number
x-510-8241400-x
Contact address
Address 1
48810 Kato Road,Suite 100E&200E
Address 2
--
City
Fremont
State code
CA
Iso country code
US
Postal code
94538
Products
  1. Product code
    HZA
    Created date
    1997-03-26
    Owner operator number
    2936532
    Harmonized identifiers (openFDA)
    Device name
    Methyl Green
    Medical specialty description
    Hematology
    Regulation number
    864.1850
    Device class
    1
Establishments and listings

MASSON TRICHROME

BIOGENEX LABORATORIES INC. · Fremont, US

Manufacture Medical DeviceReg. 3008776165HYW
Proprietary name
MASSON TRICHROME
Establishment type
Manufacture Medical Device
Registration
Registration number
3008776165
FEI number
2936532
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOGENEX LABORATORIES INC.
Address line 1
48810 Kato Road,Suite 100E&200E
City
Fremont
State code
CA
Iso country code
US
Zip code
94538
Owner operator
Firm name
BIOGENEX LABORATORIES INC.
Owner operator number
2936532
Official correspondent
First name
KRISHAN
Middle initial
L
Last name
KALRA
Phone number
x-510-8241400-x
Contact address
Address 1
48810 Kato Road,Suite 100E&200E
Address 2
--
City
Fremont
State code
CA
Iso country code
US
Postal code
94538
Products
  1. Product code
    HYW
    Created date
    2002-03-26
    Owner operator number
    2936532
    Harmonized identifiers (openFDA)
    Device name
    Stain, Trichrome, Mallory'S
    Medical specialty description
    Hematology
    Regulation number
    864.1850
    Device class
    1
Establishments and listings

MUCICARMINE

BIOGENEX LABORATORIES INC. · Fremont, US

Manufacture Medical DeviceReg. 3008776165HZC
Proprietary name
MUCICARMINE
Establishment type
Manufacture Medical Device
Registration
Registration number
3008776165
FEI number
2936532
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOGENEX LABORATORIES INC.
Address line 1
48810 Kato Road,Suite 100E&200E
City
Fremont
State code
CA
Iso country code
US
Zip code
94538
Owner operator
Firm name
BIOGENEX LABORATORIES INC.
Owner operator number
2936532
Official correspondent
First name
KRISHAN
Middle initial
L
Last name
KALRA
Phone number
x-510-8241400-x
Contact address
Address 1
48810 Kato Road,Suite 100E&200E
Address 2
--
City
Fremont
State code
CA
Iso country code
US
Postal code
94538
Products
  1. Product code
    HZC
    Created date
    2002-03-26
    Owner operator number
    2936532
    Harmonized identifiers (openFDA)
    Device name
    Mucicarmine
    Medical specialty description
    Hematology
    Regulation number
    864.1850
    Device class
    1
Establishments and listings

GIEMSA STAIN

BIOGENEX LABORATORIES INC. · Fremont, US

Manufacture Medical DeviceReg. 3008776165HYF
Proprietary name
GIEMSA STAIN
Establishment type
Manufacture Medical Device
Registration
Registration number
3008776165
FEI number
2936532
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
BIOGENEX LABORATORIES INC.
Address line 1
48810 Kato Road,Suite 100E&200E
City
Fremont
State code
CA
Iso country code
US
Zip code
94538
Owner operator
Firm name
BIOGENEX LABORATORIES INC.
Owner operator number
2936532
Official correspondent
First name
KRISHAN
Middle initial
L
Last name
KALRA
Phone number
x-510-8241400-x
Contact address
Address 1
48810 Kato Road,Suite 100E&200E
Address 2
--
City
Fremont
State code
CA
Iso country code
US
Postal code
94538
Products
  1. Product code
    HYF
    Created date
    2002-03-26
    Owner operator number
    2936532
    Harmonized identifiers (openFDA)
    Device name
    Giemsa Stain
    Medical specialty description
    Hematology
    Regulation number
    864.1850
    Device class
    1

36 records share this identifier (an establishment lists each device separately); the first 10 are shown.

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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.