PROLEX (STREPTOCCAL GROUPING LATEX KIT)
PRO-LAB, INC.
PRO-LAB DIAGNOSTICS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1318862 | 1318862 | PRO-LAB DIAGNOSTICS | 1 | Y | 2026-01-01 | 1301 BLUE RIDGE DR SUITE 101 Georgetown TX US 78626 |
| 8010383 | 1000354384 | pro-lab incorporated | 1 | N | 2026-01-01 | 20 Mural Street, Unit #4 Richmond Hill Ontario CA L4B 1K3 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 73689 | 1187119745 | K914419 | AMNIOTEST(TM) | HIO | 1993-09-01 |
| 73831 | 1111494176 | ||||
| 73831 | 1334344864 | ||||
| 73831 | 1533500742 | ||||
| 73831 | 1544268075 | ||||
| 73831 | 1634034285 | ||||
| 73831 | 1637801993 | ||||
| 73689 | 1644211005 | ||||
| 73831 | 1935457720 | ||||
| 73689 | 1031370795 | ||||
| 73689 | 1032463665 | ||||
| 73689 | 1206300839 | ||||
| 73689 | 1208835904 | ||||
| 73689 | 1213640459 | ||||
| 73689 | 1221354085 | ||||
| 73689 | 1249484962 | ||||
| 73689 | 1651412002 | ||||
| 73689 | 1664475719 | ||||
| 73689 | 1690524053 | ||||
| 73689 | 1701273323 | ||||
| 73689 | 1990567740 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HIO | 1 | 1993-09-01 |
PMN#
E.COLI 0157 LATEX TEST
PRO-LAB DIAGNOSTICS
AMNIOTEST(TM)
PRO-LAB, INC.
TRANSYSTEM AMIES W/O CHARCOAL
PRO-LAB DIAGNOSTICS
TRANSYSTEM AMIES WITH CHARCOAL
PRO-LAB DIAGNOSTICS
TRANSYSTEM LIQUID AMIES MEDIUM
PRO-LAB DIAGNOSTICS
TRANSYSTEM LIQUID STUART MEDIUM
PRO-LAB DIAGNOSTICS
LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
PRO-LAB, INC.
E. COLI 0157 LATEX TEST
PRO-LAB, INC.
ROSCO PYRR
PRO-LAB, INC.
X-ACT LDC/IND
PRO-LAB, INC.
X-ACT UREA/TDA
PRO-LAB, INC.
PROTECT T.M.
PRO-LAB, INC.
NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
PRO-LAB, INC.
MASTER KIT B
PRO-LAB, INC.
HIPPURATE HYDROLYSIS TEST
PRO-LAB, INC.
D'ALA RAPID TEST
PRO-LAB, INC.
MASTER KIT A
PRO-LAB, INC.
SUPLEX & SUPLEX DILUENT
PRO-LAB, INC.
C.L.A.T.
PRO-LAB, INC.
C.N.V.T.
PRO-LAB, INC.
CAMPYLOBACTER SUPPLEMENT -SKIRROW
PRO-LAB, INC.
CAMPYLOBACTER SUPPLEMENT-BLASER/WANG
PRO-LAB, INC.
MUCOLYSE
PRO-LAB, INC.
YEAST DIALYSATE
PRO-LAB, INC.
CUSTOM OPEN HEART TRAY
PRO-LAB, INC.
INTRAVENOUS START KIT
PRO-LAB, INC.
DRESSING CHANGE TRAY STERILE 5002
PRO-LAB, INC.
VENESECTION TRAY, ADULT 6050
PRO-LAB, INC.
SUTURE TRAY
PRO-LAB, INC.
O.B. BASIN SET
PRO-LAB, INC.
DR. GOULD HAND PACK SUSTOM STERIL
PRO-LAB, INC.
GUDID#
AmnioTest (Nitrazine yellow swab 100 box) - The AmnioTest™ is designed to assist in the detection of rupture of the fetal membranes, based on elevation of the pH in the upper vagina consistent with leakage of amniotic fluid. The sterile swab impregnated with nitrazine yellow dye, offers a rapid, reliable, cost effective and simple to use point-of-care test to aid in the detection of amniotic fluid in patients with suspected PROM.
2022-12-26
AmnioTest (Nitrazine yellow swab 20 box) - The AmnioTest™ is designed to assist in the detection of rupture of the fetal membranes, based on elevation of the pH in the upper vagina consistent with leakage of amniotic fluid. The sterile swab impregnated with nitrazine yellow dye, offers a rapid, reliable, cost effective and simple to use point-of-care test to aid in the detection of amniotic fluid in patients with suspected PROM.
2022-12-26
AmnioTest (Nitrazine yellow swab) - The AmnioTest™ is designed to assist in the detection of rupture of the fetal membranes, based on elevation of the pH in the upper vagina consistent with leakage of amniotic fluid. The sterile swab impregnated with nitrazine yellow dye, offers a rapid, reliable, cost effective and simple to use point-of-care test to aid in the detection of amniotic fluid in patients with suspected PROM.
2022-12-26
Legionella DFA Mounting Medium - Mounting Medium
2022-12-25
AmnioTest Colour Cards - AmnioTestTM is designed to assist in the detection of rupture of the fetal membrane. It offers the most efficient, cost effective, reliable, and simple to use point-of-care screen test to aid in the detection of amniotic fluid in near-term patients. Along with a simple quality control regimen, AmnioTestTM is an invaluable tool for OB-GYN and L+D clinics.50 cards
2022-12-26
E. coli O157 Antiserum (3ml) - PL.6250
2022-12-26
Prolex E. coli O91 Latex Reagent - PL.1078
2022-12-26
Prolex E. coli Non-O157 Negative Control Latex Reagent - PL.1077
2022-12-26
Prolex E. coli O145 Latex Reagent - PL.1076
2022-12-26
Prolex E. coli O121 Latex Reagent - PL.1075
2022-12-26
Prolex E. coli O111 Latex Reagent - PL.1074
2022-12-26
Prolex E. coli O103 Latex Reagent - PL.1073
2022-12-26
Prolex E. coli O45 Latex Reagent - PL.1072
2022-12-26
Prolex E. coli O26 Latex Reagent - PL.1071
2022-12-26
Prolex E. coli Non-O157 Identification Kit - The ProlexTM E. coli Non-O157 Kit provides an easy to use, reliable and affordable way to identify the six most common STEC producing serotypes in North America. The kit uses our blue carboxylated latex particles labelled with antibodies to E. coli O26, E. coli O45, E. coli O103, E. coli O111, E. coli O121 and E. coli O145 to perform a simple agglutination test. This kit is a great addition to our line of products for the detection of STEC especially when used in conjunction with our ProlisaTM EHEC EIA Kit (PL.2001) and the ProlexTM E.coli O157 Latex Agglutination Kit (PL.070B and PL.071B). Each non-O157 kit comes with a negative control and sufficient agglutination cards and mixing sticks.
2022-12-26
Prolex E. coli O157 Latex Reagent Control Negative - Negative Control Latex Reagent
2022-12-26
Prolex E. coli O157 Latex Test Reagent Kit (100 tests) - "ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar ""O"" and ""H"" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls."
2022-12-26
Prolex E. coli O157 Latex Test Reagent Kit (50 tests) - "ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar ""O"" and ""H"" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls."
2022-12-26
Monovalent Flagella Salmonella Antisera - Factor z6 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-24
Monovalent Flagella Salmonella Antisera - Factor 7 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-24
Monovalent Flagella Salmonella Antisera - Factor 6 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-24
Monovalent Flagella Salmonella Antisera - Factor 5 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-24
Monovalent Flagella Salmonella Antisera - Factor 2 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor z29 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor z10 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor z32 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor z24 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor z23 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Z4 Complex - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor z - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor y - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor r - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor z28 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor z13 - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor v - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor w - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factors l, v - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factors l, w - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - L Complex - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23
Monovalent Flagella Salmonella Antisera - Factor k - A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
2022-12-23