# 2,3-diphosphoglyceric acid test system

*/Products/2,3-diphosphoglyceric_acid_test_system*

In this classification, 2,3-diphosphoglyceric acid test system connotes a device used to measure 2,3-diphosphoglyceric acid levels. US FDA regulates 2,3-diphosphoglyceric acid test system under 21 CFR 862.1255 and under FDA product code JLY.

## Product Bo M

**Input To**:
- [Run Photometric Assay](/Processes/Run_Photometric_Assay)
- [Perform Quality Control](/Processes/Perform_Quality_Control)
**Summary**: An in-vitro diagnostic reagent kit that quantifies 2,3-diphosphoglyceric acid in a blood sample through a coupled enzymatic reaction read photometrically. It packages reagents, standards, and a protocol that feed laboratory assay workflows producing a reported analyte concentration.
**Output Of**:
- [Formulate Diagnostic Reagent](/Processes/Formulate_Diagnostic_Reagent)
**Components**:
- Name: Enzyme Reagent · Quantity Note: drives the coupled assay reaction · Required Input: Lyophilized Enzymes
- Name: Assay Buffer Solution · Quantity Note: maintains reaction pH · Required Input: Buffer Salts
- Name: Calibrator Standard · Quantity Note: known-concentration reference for the curve · Required Input: 
- Name: Control Sample · Quantity Note: verifies run validity at two levels · Required Input: 
- Name: Reagent Vials · Quantity Note: hold each liquid component · Required Input: Borosilicate Glass
- Name: Sample Cuvettes · Quantity Note: photometric read vessels · Required Input: Optical Plastic
- Name: Instructions For Use Insert · Quantity Note: protocol and reference ranges · Required Input: Paper
**Packaged In**:
- [Insulated Diagnostic Kit Box](/Products/Insulated_Diagnostic_Kit_Box)
**By Product Of**:
- [Biohazard Liquid Waste](/Products/Biohazard_Liquid_Waste)
**Delivered As**:
- [Reagent Rental Supply Contract](/Services/Reagent_Rental_Supply_Contract)
**Described By**:
- [Assay Lot Record](/Datasets/Assay_Lot_Record)
**Originates In**:
- [United States](/Places/United_States)
**Physical Good**: true
**Produced With**:
- [Reagent Filling Line](/Products/Reagent_Filling_Line)
- [Lyophilizer](/Products/Lyophilizer)
**Assembled From**:
- [Reagent Pack](/Products/Reagent_Pack)
- [Calibration And Control Set](/Products/Calibration_And_Control_Set)
**Consumes To Make**:
- [Purified Water](/Products/Purified_Water)
- [Stabilizer Additives](/Products/Stabilizer_Additives)
**Has Measurement**:
- [Assay Sensitivity](/Metrics/Assay_Sensitivity)
- [Measuring Range](/Metrics/Measuring_Range)
- [Reagent Shelf Life](/Metrics/Reagent_Shelf_Life)
- [Coefficient Of Variation](/Metrics/Coefficient_Of_Variation)
**Transforms Into**:
- [Laboratory Test Result](/Products/Laboratory_Test_Result)
- [Clinical Assay Panel](/Products/Clinical_Assay_Panel)

## Neighborhood

### Parent

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### Delivered as

- [Reagent Reagent-Rental Program](/Services/Reagent_Reagent-Rental_Program) — delivered as · Services
- [Reference Laboratory Testing](/Services/Reference_Laboratory_Testing) — delivered as · Services

### Input to

- [Perform Spectrophotometric Analysis](/Processes/Perform_Spectrophotometric_Analysis) — input to · Processes
- [Conduct quality control process](/Processes/Conduct_quality_control_process) — input to · Processes
- [Enzyme Activity Assay](/Processes/Enzyme_Activity_Assay) — input to · Processes
- [Measure Erythrocyte Metabolite](/Processes/Measure_Erythrocyte_Metabolite) — input to · Processes

### Output of

- [Diagnostic Reagent Formulation](/Processes/Diagnostic_Reagent_Formulation) — output of · Processes
- [Assemble Reagent Kit](/Processes/Assemble_Reagent_Kit) — output of · Processes

### Transforms into

- [Laboratory Analysis Report](/Products/Laboratory_Analysis_Report) — transforms into · Products
- [Clinical Assay Panel](/Products/Clinical_Assay_Panel) — transforms into · Products

### Assembled from

- [Reagent Packet](/Products/Reagent_Packet) — assembled from · Products
- [Calibrator and Control Pack](/Products/Calibrator_and_Control_Pack) — assembled from · Products

### Requires input

- [Lyophilized Enzyme Powder](/Products/Lyophilized_Enzyme_Powder) — requires input · Products
- [Optical Grade Plastic](/Products/Optical_Grade_Plastic) — requires input · Products
- [Paper](/Products/Paper) — requires input · Products
- [Borosilicate Glass](/Products/Borosilicate_Glass) — requires input · Products
- [Buffer Salts](/Products/Buffer_Salts) — requires input · Products
- [Coupling Enzyme](/Products/Coupling_Enzyme) — requires input · Products

### Composed of

- [Reagent Vial](/Products/Reagent_Vial) — composed of · Products
- [Instruction For Use Insert](/Products/Instruction_For_Use_Insert) — composed of · Products
- [Calibration Standard Set](/Products/Calibration_Standard_Set) — composed of · Products
- [Calibration Standard](/Products/Calibration_Standard) — composed of · Products
- [Assay Buffer](/Products/Assay_Buffer) — composed of · Products
- [Sample Cuvettes](/Products/Sample_Cuvettes) — composed of · Products
- [Control Sample](/Products/Control_Sample) — composed of · Products
- [Quality Control Material](/Products/Quality_Control_Material) — composed of · Products
- [Substrate Solution](/Products/Substrate_Solution) — composed of · Products
- [Enzyme Reagent](/Products/Enzyme_Reagent) — composed of · Products

### Consumes

- [Stabilizer Additive](/Products/Stabilizer_Additive) — consumes · Products
- [Purified Water](/Products/Purified_Water) — consumes · Products
- [Buffer Salt](/Products/Buffer_Salt) — consumes · Products
- [Coenzyme Reagent](/Products/Coenzyme_Reagent) — consumes · Products
- [Purified Enzyme](/Products/Purified_Enzyme) — consumes · Products

### Produced with

- [Lyophilizers](/Products/Lyophilizers) — produced with · Products
- [Reagent Filling Line](/Products/Reagent_Filling_Line) — produced with · Products

### Measured by

- [Reagent Shelf-Life Stability](/Metrics/Reagent_Shelf-Life_Stability) — measured by · Metrics
- [Coefficient Of Variation](/Metrics/Coefficient_Of_Variation) — measured by · Metrics
- [Assay Sensitivity](/Metrics/Assay_Sensitivity) — measured by · Metrics
- [Shelf Life](/Metrics/Shelf_Life) — measured by · Metrics
- [Precision](/Metrics/Precision) — measured by · Metrics
- [Measurement Range](/Metrics/Measurement_Range) — measured by · Metrics

### Originates in

- [United States](/Places/United_States) — originates in · Places

### Described by

- [Assay Lot Record](/Datasets/Assay_Lot_Record) — described by · Datasets
- [Assay Package Insert](/Datasets/Assay_Package_Insert) — described by · Datasets

### By product of

- [Biohazard Liquid Waste](/Products/Biohazard_Liquid_Waste) — by product of · Products
- [Laboratory Liquid Waste](/Products/Laboratory_Liquid_Waste) — by product of · Products

### Packaged in

- [Insulated Diagnostic Kit Box](/Products/Insulated_Diagnostic_Kit_Box) — packaged in · Products
- [Diagnostic Kit Box](/Products/Diagnostic_Kit_Box) — packaged in · Products