FDA.reportPublic FDA data

Rabbit Coagulase Plasma (1x20ml)

Primary DI
05060472467539
Brand
Rabbit Coagulase Plasma (1x20ml)
Company
PRO-LAB, INCORPORATED
Model
PL.850-20
Catalog number
PL.850-20
Device description
Rabbit Coagulase Plasma is a standardized, lyophilised rabbit plasmaused for the qualitative detection of the coagulase enzyme produced byStaphylococcus aureus.
Published
2022-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JTLPlasma, Coagulase, Human, Horse And Rabbit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTLPlasma, Coagulase, Human, Horse And RabbitMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060472467539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060472467539050604724675395060472467539

GMDN Terms#

Term, Definition table
TermDefinition
Coagulase production microbial reagent IVDA substance or reactant intended to be used in microbial testing to detect the enzyme coagulase, produced by a microorganism isolated from a clinical specimen by culture.

Regulatory Flags#

DUNS number
960418395
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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20628429001220AmnioTest (Nitrazine yellow swab 20 box)PL.901-20PL.901-202022-12-26
30628429001227AmnioTest (Nitrazine yellow swab 100 box)PL.901PL.9012022-12-26
10628429001742Legionella DFA Mounting MediumPL.213PL.2132022-12-25
10628429001049Prolex E. coli O157 Latex Test Reagent Kit (50 tests)PL.070BPL.070B2022-12-26
10628429001056Prolex E. coli O157 Latex Test Reagent Kit (100 tests)PL.071BPL.071B2022-12-26
10628429001100Prolex E. coli O157 Latex Reagent Control NegativePL.076BPL.076B2022-12-26
10628429001124Prolex E. coli Non-O157 Identification KitPL.1070PL.10702022-12-26
10628429001131Prolex E. coli O26 Latex ReagentPL.1071PL.10712022-12-26
10628429001148Prolex E. coli O45 Latex ReagentPL.1072PL.10722022-12-26
10628429001155Prolex E. coli O103 Latex ReagentPL.1073PL.10732022-12-26
10628429001162Prolex E. coli O111 Latex ReagentPL.1074PL.10742022-12-26
10628429001179Prolex E. coli O121 Latex ReagentPL.1075PL.10752022-12-26
10628429001186Prolex E. coli O145 Latex ReagentPL.1076PL.10762022-12-26
10628429001193Prolex E. coli Non-O157 Negative Control Latex ReagentPL.1077PL.10772022-12-26
10628429001209Prolex E. coli O91 Latex ReagentPL.1078PL.10782022-12-26
10628429001216E. coli O157 Antiserum (3ml)PL.6250PL.62502022-12-26
10628429001254AmnioTest Colour CardsPL.902PL.9022022-12-26
10628429000080Prolex Streptococcal Grouping Latex KitPL.030PL.0302022-12-25
10628429000110Prolex Streptococcal Grouping Reagent Latex Suspension Group APL.031PL.0312022-12-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838022227REMELREMEL, INC.JTL2023-01-03
00848838022241REMELREMEL, INC.JTL2023-01-03
00848838022258REMELREMEL, INC.JTL2023-01-03
00848838022265REMELREMEL, INC.JTL2023-01-03
05060472467515Rabbit Coagulase Plasma (10x3ml)PRO-LAB, INCORPORATEDJTL2022-12-20
05060472467522Rabbit Coagulase Plasma (1x10ml)PRO-LAB, INCORPORATEDJTL2022-12-20
05060472467546Rabbit Coagulase Plasma (1x30ml)PRO-LAB, INCORPORATEDJTL2022-12-20
00819398026581Coagulase Cryo™HARDY DIAGNOSTICSJTL2020-08-06
00819398026574Coagulase Cryo™HARDY DIAGNOSTICSJTL2020-08-06
00816576028207CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
00816576028221CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
00816576028191CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
00816576028214CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
30382902406588BD BBL™ Coagulase Plasma, RabbitBECTON, DICKINSON AND COMPANYJTL2018-05-25
30382902406618BD BBL™ Coagulase Plasma, RabbitBECTON, DICKINSON AND COMPANYJTL2018-05-25
30382902408261BD BBL™ Coagulase Plasma, Rabbit with EDTABECTON, DICKINSON AND COMPANYJTL2018-05-25
30382902408278BD BBL™ Coagulase Plasma, Rabbit with EDTABECTON, DICKINSON AND COMPANYJTL2018-05-25